By Michael Mezher – 21 February 2017

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks to dramatically alter the US Food and Drug Administration’s (FDA) process for inspecting device manufacturers.

Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings.

“The current device facility inspection process lacks transparency, predictability and consistency between facilities,” Isakson said. “This bill is designed to improve communication and consistency in the device facility inspections process, which will allow both FDA and device manufacturers to make more efficient use of resources.”

According to the bill, inconsistencies in how inspections are conducted across FDA’s foreign and domestic offices create challenges for device makers.

“The frequency and nature of inspections of device establishments are not consistently risk-based and a comprehensive, transparent, risk-based approach to inspections would result in greater focus on more significant risks to public health while reducing the burdens on establishments with a strong track record of compliance,” the bill states.

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By Charlie Osborne for Zero Day – February 21, 2017

The heat is on medical device vendors, healthcare providers, and security firms to tackle the emerging problem of cyberattacks focused on the Internet of Medical Things (IoMT).

Hardly a week goes by when we don’t hear of the latest company to fall victim to hackers, but the ability to compromise medical devices may go far beyond the consequences of standard malware infections and the theft of personally identifiable information (PII).

Attacks against medical devices can occur due to social engineering and network infiltration, as well as vulnerabilities in hardware and software. The most common threats today include ransomware, man-in-the-middle (MiTM) attacks, phishing and, on occasion, physically compromising devices.

Strong networks can create a barrier between attackers and healthcare systems, but medical devices can suffer from the same vulnerabilities, exploits, outdated firmware and security flaws that plague traditional computer systems.

Medical device security hit the spotlight in 2012 when IOActive security researcher Barnaby Jack discovered transmitter security flaws which could be used to deliver lethal shocks to pacemakers. Recently, medical equipment maker St. Jude Medical was forced to patch security holes in the firm’s cardiac devices.

While medical devices may be targeted for the purposes of causing harm to individual patients or blackmail, one of the main reasons appears to be for financial gain.

In March 2016, US hospital chain MedStar’s IT infrastructure was crippled after a successful malware attack, and California’s Hollywood Presbyterian Medical Center paid attackers thousands of dollars after ransomware disrupted critical services in the same year.

Speaking to ZDNet, Jason Allaway, vice president of RES UK & Ireland, said the main threat to hospitals is ransomware due to the “devastatingly effectiveness” of attacks — and “because the consequence of losing data goes far beyond a financial cost.”

“Unlike data held by other organizations, such as those operating in finance, medical data holds a life or death value,” Allaway says. “Medical organizations can’t even give out the most basic of painkillers if their data is not fully available. […] Unless hospitals have a stringent backup policy, there is little option other than paying a ransom so that staff can continue to provide critical medical care.”

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product:

• Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
• Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
• Product Code: KWS, PAO
• Lot Numbers: All lots with part number 115340; See full list of lot numbers
• Distribution Dates: October, 2008 to September, 2015
• Manufacturing Dates: August 25, 2008 to September 27, 2011
• Devices Recalled: 3662

  Device Use

  The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.

  Reason for Recall

  Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.

  Who May be Affected

  • Health care providers using this device during reverse shoulder replacement surgeries
  • Patients receiving total shoulder replacements using this device

  What to Do

  On December 20, 2016 Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice asked customers to:

  • Review the safety notice and ensure appropriate staff is aware of the notice.
  • Identify and quarantine any affected devices in stock.
  • The Zimmer Biomet sales representative will remove the affected device from the facility.
  • Complete and return the Certificate of Acknowledgement form within 3 days via email to corporatequality.postmarket@zimmerbiomet.com.
  • Retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit.

  The notice also stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.

  Contact Information

  Health care professionals and consumers with questions are instructed to contact the 411 Technical Services by phone at (574) 371-3071 or by email at corporatequality.postmarket@zimmerbiomet.com with any questions related to this recall.

  Date Recall Initiated:

  December 15, 2016

  How do I report a problem?

  Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

  Lot Numbers:

  041870 041880 041890 052860 060500 070330 079900 085130 118250 118260 118270 118280 118290 118300 118340 118350 118360 118370 118380 118390 132020 132030 153330 153340 153350 153360 153370 153380 153390 153400 153410 153420 153430 159650 159660 161960 172670 215990 216000 216010 256990 257000 257010 257020 278300 278310 278320 278330 278550 278560 278580 278590 300090 300100 300110 300120 300130 300140 300150 310580 310590 310600 310610 310620 329390 349140 349150 351030 351040 367300 367310 367320 367330 367340 367350 367360 367370 367380 372290 372310 372320 385090 402880 411980 413530 415040 415050 415060 415070 415080 415090 420630 424640 424650 424660 424670 424680 424690 424700 424710 424720 424730 424740 436760 436770 440500 457900 492370 492380 492390 492400 492410 492420 492430 492440 492450 501830 551660 556800 556820 557440 557620 557840 558840 558880 558890 558900 558910 558920 561910 562430 563440 568870 569050 569060 569070 569080 569090 569100 569120 569130 569140 569150 569690 578920 595090 597740 607390 607400 607410 607420 607430 609780 613990 630660 633600 634660 634860 635190 637190 637240 641220 641350 641390 641680 648790 648800 648810 648820 648830 648860 659950 659960 659970 659980 659990 660000 660010 660020 660030 660040 668550 668560 668570 668580 668590 668600 668610 668620 668630 668970 674320 677090 677100 677110 677140 677150 677160 677170 677180 677190 677200 680720 680730 680740 680750 680760 697100 697110 697120 697130 697150 697160 697170 697180 697190 697200 704050 704810 706840 712090 715990 716200 723830 723850 723870 723880 725550 725560 725760 726590 726710 734810 745350 762930 764700 765560 765830 765870 767360 767370 771810 788670 788680 788690 791260 791270 791280 818790 839150 846190 846200 846210 846230 846240 846280 846290 846300 846310 846320 846330 848110 848120 848130 848140 848150 848160 848170 848190 848200 848210 848220 848230 848240 848250 848260 848270 848280 848290 848300 848310 848320 854210 854220 854240 854250 854260 854290 854300 854310 854320 863330 889690 908010 950390 950400 963700 974990 981260 981270

  U.S. Food and Drug Administration
  10903 New Hampshire Avenue
  Silver Spring, MD 20993
  1-888-INFO-FDA (1-888-463-6332)

ATLANTA, GA–(Marketwired – Feb 15, 2017) – Medovex Corp. ( NASDAQ : MDVX ), a developer of medical technology products, today announced that the Company successfully completed its final CE Mark audit meeting. The review of the Company’s DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval.

Patrick Kullmann, Medovex President and COO, stated, “We’re very pleased to have completed our certification audit of the DenerveX System February 7-9, 2017 at the Company’s Atlanta based offices. Our in-house development team, along with several representatives from our world-class suppliers and consultants, contributed extensively during this process due to their vast expertise in R&D, manufacturing, electro-surgery, regulatory, quality, and sterilization processes.”

Kullmann further stated, “Upon successfully completing this audit, the CE certificate would generally be expected to be issued paving the way to the future launch of the DenerveX System in the EU and other countries which accept the CE Mark.”

Previously on January 3, 2017, the Company announced it had successfully received certification of compliance for its DenerveX System from SGS S.A. a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union.

Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device.

Jarrett Gorlin, Medovex CEO, commented, “I’m very proud of our team and how they prepared for and handled this important event. Together, we have spent countless hours in anticipation of meeting with representatives of LNE/GMED. Although a date has not been provided for the anticipated receipt of the CE certificate or the launch of the product, we believe we remain well on our way to completing the final regulatory step in the process of achieving CE Marking.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options, and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system.
DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

February 14, 2017

By NEIL VERSEL – February 2017

There are plenty of unknowns about newly installed Health and Human Services Secretary Dr. Tom Price, but two things are pretty clear: He knows the intricacies of the healthcare industry and he is deferential to the role of physicians.

Friday, Price became the 23rd HHS secretary after the Senate confirmed his nomination in the wee hours by a 52-47 vote that broke strictly along party lines. An orthopedic surgeon who previously represented suburban Atlanta in Congress, Price is the first physician to head HHS since Dr. Louis Sullivan in 1989-93.

“It’s significant that he’s a physician,” said Julius W. Hobson, a senior policy advisor in the Washington office of law firm Polsinelli. “They have different viewpoints” than other bureaucrats, said Hobson, a former American Medical Association lobbyist who has known Price since 1994.

“He, [Steven] Mnuchin at Treasury and [James] Mattis at Defense are probably the cream of the crop in this administration in terms of experience and knowledge,” Hobson said.

Hobson noted that Price has long been involved in organized medicine, via the AMA, the Medical Association of Georgia and, yes, the controversial Association of American Physicians and Surgeons. “Even in the House, he was active in the AMA,” Hobson noted.

In shaping healthcare policy, Price always has physician interests in mind. “He will first and foremost look at how public policy will affect the practice of medicine,” according to Hobson.

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FEBRUARY 9, 2017 BY BRAD PERRIELLO

Intuitive Surgical (NSDQ:ISRG) last week warned of the risks posed to its business by the geopolitical shifts of the past year, including the likely repeal of Obamacare, the U.S.’s threatened abrogation of the North American Free Trade Agreement and Great Britain’s pending exit from the European Union.

In its annual report filed Feb. 3, the robot-assisted surgery market’s leading player warned that a repeal of the Patient Protection & Affordable Care Act, enacted in 2010, “could have a negative impact on the demand for our products.”

“Any changes of, or uncertainty with respect to future reimbursement rates, or changes in hospital admission rates could impact our customers’ demand for our products and services, which in turn could impact our ability to successfully commercialize our products, or could limit or eliminate our spending on certain development projects. These changes could have a material adverse effect on our business, financial condition, results of operations or cash flows,” the company wrote in the filing. “We are unable to predict whether other healthcare policies, including policies stemming from legislation or regulations affecting our business may be proposed or enacted in the future; what effect such policies would have on our business; or the effect ongoing uncertainty about these matters will have on the purchasing decisions of our customers.”

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