The European Commission has caved to pressure on extending IVDR. Now what?

The Latest

• 

  Abbott, Dexcom could benefit from CGM use jump among Type 2 diabetes patients: report

  The population could drive the next wave of demand for devices to track and control diabetes, Jefferies analysts predict, based on polling of roughly 50 endocrinologists and general practitioners.

  Medical Devices

• 

  Withings gets FDA nod for AFib-detecting wearable, taking on Apple

  The device, which is capable of detecting atrial fibrillation, combines an analog watch face with health features found in digital smartwatches. The French company joins Apple, Fitbit and Samsung in a crowded market.

  Medical Devices

• 

  FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

  The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.

  Medical Devices

• 

  European Commission adds 2 modules to delayed Eudamed database, with no follow-on timeline

  Sections on UDI/device registration, and Certificates and Notified Bodies are now available for voluntary use but some features are missing.

  Medical Devices

• 

  Best Buy's latest health acquisition builds on plan to expand at-home care

  The consumer electronics giant is buying UK-based Current Health, whose platform combines remote monitoring, telehealth and data from wearables, as well as algorithms to identify when a patient needs clinical attention.  

  Digital Health

• 

  Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff

  The system will hit the European market after the medtech giant unveiled it in 2019 and delayed the timeline amid the pandemic. Medtronic will take on market leader Intuitive Surgical and an upcoming product from J&J.

  Medical Devices

• 

  4 takeaways from a bumper year of M&A medtech activity (so far)

  After hunkering down last year, many companies entered 2021 with large cash reserves and acquisition targets that included players lacking scale to weather the downturn.

  Medical Devices

• 

  FDA beefs up surgical stapler oversight after injuries, death reports

  While medtechs like J&J and Medtronic backed the broad change, the final rule held firm on several contentious elements. The agency also updated labeling guidance of both staplers and staples due to patient safety risks.

  Medical Devices

• 

  Quidel hikes revenue forecast, riding COVID-19 testing wave

  CEO Doug Bryant cautioned that "demand can change very quickly," while Craig-Hallum analysts said future coronavirus-related sales remain "unforecastable."

  Diagnostics

• 

  Deep Dive

  How Morgan Health hopes to finally move the needle on employer health costs: 5 insights from a chat with the venture's CEO

  Morgan Health learned a lot from Haven, but is a different beast with better knowledge of the buy-in needed to disrupt the health benefits space, CEO Dan Mendelson told Healthcare Dive.

  Policy & Regulation

• 

  Deep Dive

  Will a software bill of materials help or hurt medical device cybersecurity?

  President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.

  Medical Devices

• 

  Medtechs opened 2021 with a flurry of M&A and have not stopped spending since

  With deals ranging from tuck-ins to multibillion-dollar takeovers, here's a roundup of the M&A spree so far this year after activity came to a near halt amid the unpredictability of 2020.

  Medical Devices

• 

  Labcorp, PerkinElmer latest to target COVID-flu combo test market

  FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.  

  Policy & Regulation

• 

  Boston Scientific inks $1.75B deal for Baylis, biggest in string of M&A

  SVB Leerink analysts wrote the acquisition will add needed support in electrophysiology and structural heart, two of the highest growth markets within cardiology. It's the medtech's fifth acquisition of 2021.

  Medical Devices

• 

  False positives spur Ellume recall of COVID-19 tests from DoD, retailers

  The company, which got a $231 million defense contract in February, identified a manufacturing issue and has implemented "additional controls." The move comes as the U.S. races to boost the nation's supply of antigen tests.

  Policy & Regulation

• 

  Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

  The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.

  Medical Devices

• 

  FDA resists industry push to nix De Novo inspections in final rule

  "The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green.

  Medical Devices

• 

  Digital health funding shatters record again with $21.3B so far this year

  This year, mental health is the top funded clinical indication with $3.1 billion raised, followed by digital health tools for managing cardiovascular disease, diabetes, primary care and oncology.

  M&A

• 

  MCIT, cyber, RWE and 3 more takeaways from AdvaMed's 2021 conference

  The medtech industry gathered virtually and in person for the lobby's annual conference, with topics ranging from the kill-off of the breakthrough device payment pathway to the pandemic upending CDRH's 2021 reset.

  Medical Devices

• 

  Acon gets FDA nod for home COVID-19 test kit amid surging US demand

  The diagnostics maker secured authorization for its over-the-counter antigen test amid a nationwide testing shortage. Abbott and Quidel are scaling up production but it could take months to boost output.

  Policy & Regulation

• 

  FDA's real-world evidence push hampered by data challenges, 'million-dollar question'

  While the agency wants to tap information like electronic health records and wearables to make pre- and postmarket decisions, these sources do not have the same quality controls as clinical trials. 

  Medical Devices

• 

  EU shares guide to MDR's 22 rules for classifying medical devices

  If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the company has its registered place of business.

  Medical Devices

• 

  Ransomware attacks put availability of medical devices at risk: FDA cyber chief

  Industry reached a "watershed moment" earlier this year when a device outage caused by malware endangered patient lives, Kevin Fu, acting director of cybersecurity at CDRH said. "That was something we haven't seen before."

  Medical Devices

• 

  Doctors slam surprise billing rule that details dispute resolution process

  Making a health plan's "qualifying payment amount" the primary factor in independent dispute resolution arbitration will "cause large imaging cuts and reduce patient access to care," the American College of Radiology said.

  Policy & Regulation

• 

  FDA hits nearly all MDUFA IV commitments despite pandemic disruptions

  The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.

  Medical Devices

More stories