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Medtronic Settles Deceptive Advertising Lawsuit for $12M

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multi-state settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse. The complaint alleged that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about the device’s safety, comparative efficacy and superiority to expand its market. Specifically, the complaint alleged that to promote the device, used in spinal fusion procedures, Medtronic paid millions in consulting...

FDA proposes new fast path to market for certain medical devices

The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval. Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times. The proposals make good on President Donald Trump’s promise to cut regulations and sparked concern from public health advocates who fear the moves will harm patients. Already dozens of...

Europe -
Dans quels cas les LAP sont des DM - Affaire Snitem et Philips France c/ Ministre de la santé - arrêt CJUE sur questions préjudicielles

La CJUE vient de rendre sa décision dans l'affaire C329/16 Snitem et Philips France c/ Ministre de la santé, et a entériné les conclusions de l’Avocat Général. La CJUE retient qu'un logiciel d'aide à la prescription (LAP) constitue un dispositif médical au sens de la Directive 93/42 dès lors que l’une des fonctionnalités de ce logiciel permet l’exploitation de données propres à un patient, aux fins, notamment, de détecter les contre‑indications, les interactions médicamenteuses et les posologies excessives, et ce même si un tel logiciel n’agit pas directement dans ou sur le corps humain. La...

Experts Look For Lessons in FDA's Pacemaker Cybersecurity Recall

In a paper in JAMA this week, two experts highlight lessons that could be learned from the US Food and Drug Administration's (FDA) first major cybersecurity-related recall for a permanent implantable medical device. Background In August, Abbott announced a voluntary recall of some 465,000 pacemakers to patch cybersecurity vulnerabilities that were first acknowledged by FDA and the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) in January. The recall affected six pacemakers Abbott acquired in its purchase of St. Jude Medical earlier this...

FDA Backs Off From Regulating Certain Types of Health Software

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated. One of the draft guidances, the 13-page “ Clinical and Patient Decision Support Software ,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated. “For example, generally, CDS that allows for the provider to independently review the...

International -
Edwards Buys Harpoon for up to $250 Million

Just before the market closed on Wednesday, Edwards Lifesciences said it had acquired Harpoon Medical for $100 million, plus up to $150 million in pre-specified milestone payments over the next decade. Edwards Lifesciences may be best known for its leadership in transcatheter valve therapies, but the company appears to be turning to its surgical valve portfolio as part of its growth strategy for the coming year. The company's acquisition of Harpoon Medical, announced Wednesday afternoon, is the first major indicator of this shift. Harpoon is developing beating-heart repair technology for...

Discovery -
How a New Device Could Ease the Pain of Biologics

Takeda Pharmaceutical and Portal Instruments are teaming up to develop a new device to deliver drugs through a pressurized liquid, potentially eliminating the need for needle-based injections. Portal Instruments , a new medical device startup out of Cambridge, MA, announced a partnership this week with Japanese pharmaceutical giant Takeda to develop a new needle-free drug delivery device to help treat chronic conditions. The new device has the potential to treat a wide range of conditions that require drugs to be injected through a needle, specifically GI diseases like ulcerative colitis and...

Discovery -
Electronic 'Nose' Offers Rapid Epilepsy Diagnosis

An electronic "nose" that measures various compounds in exhaled breath reliably distinguishes patients with epilepsy from controls, new research shows. The noninvasive diagnostic tool is faster, less costly, and less invasive than electroencephalography (EEG) — the standard technique to diagnose epilepsy. Patients simply insert a small hand-held device into their mouth and breath into it for 5 minutes. "It's super quick, it's super cheap, and it's super easy to use," Cecile C. de Vos, PhD, Montreal Neurological Institute, McGill University, Quebec, Canada, and Department of Neurology and...

International -
Biocompatibility Testing: Are You Considering Interactions Between Packaging and Devices?

MD&M Minneapolis speakers point out potential sources of extractables and leachables to consider. The biocompatibility and toxicological attributes of medical device packaging materials and systems should be evaluated, according to the general requirements section of ISO 11607. But if this recommendation hasn’t been enough of a reason to consider biocompatibility requirements in your evaluation plan, revisions to ISO 10993 just might be. At MD&M Minneapolis last month, Frank Bieganousky, director of package and medical device testing at Whitehouse Labs, a division of AMRI, told the...

International -
OrbiMed Founder Sam Isaly Accused of Sexual Harassment

Five people who once worked at the hedge fund said Sam Isaly harassed female employees for years, according to an investigative report released this week. Though Isaly denied the allegations, OrbiMed said it has retained an independent law firm to investigate the matter, and called the incidents cited "concerning." Sexual harassment scandals are not limited to Hollywood, famous broadcasters, and politicians. This week STAT broke a sexual harassment story that touches medtech, as it involves the founder of one of the industry's largest hedge funds. According to the investigative report ,...



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