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.

By Greg Slabodkin • Oct. 7, 2021

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.

Oct. 7, 2021

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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.

By Ricky Zipp • Oct. 6, 2021

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.

By Nick Paul Taylor • Oct. 6, 2021

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.

By Susan Kelly • Oct. 5, 2021

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.

By Nick Paul Taylor • Oct. 5, 2021

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. 

By Greg Slabodkin • Oct. 4, 2021

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.

By Nick Paul Taylor • Oct. 4, 2021

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.

Oct. 4, 2021

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."

By Greg Slabodkin • Oct. 1, 2021

AdvaMed defends J&J in $344M row with California court over mesh marketing

The lobby group filed an amicus curiae brief asking the appeals court to reverse the judgment against J&J, arguing it "undermines a manufacturer's ability to rely on FDA input when it comes to the adequacy of device labeling."

By Nick Paul Taylor • Oct. 1, 2021

How much is too much? OIG warns about booze for doctors in medtech speaker programs

"This is a chance to take a hard look and see if it's worth it. The document may signal that some types of practices are just too risky," said Ben Wallfisch, a senior counsel with the Office of Counsel to the HHS Inspector General. 

By Kim Dixon • Oct. 1, 2021

Bayer posts final analysis of Essure adverse events to FDA

The last report, which is based on social media posts, completes the deal the company made with the agency.

By Nick Paul Taylor • Sept. 30, 2021

MedTech Europe director warns about EU's turbulent switch to IVDR

Oliver Bisazza told the AdvaMed conference this week that while the European Union will "needlessly lose a great deal of tests" in the transition to the In Vitro Diagnostic Regulation, he is confident decision makers will "course correct."

By Nick Paul Taylor • Sept. 30, 2021

CMS defends proposal to nix MCIT pathway, medtechs hold out hope

If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.

By Greg Slabodkin • Sept. 29, 2021

FDA medical device regs, safety checks questioned by AMA ethics journal

As it's typically safer to discontinue the use of a drug than an implant, it "might be reasonable" to hold some devices to higher standards, suggests Ariel Wampler, author and plastic and reconstructive surgery physician.

By Nick Paul Taylor • Sept. 29, 2021

CDRH's 2021 'reset' shunted again as COVID-19 dominates workload

Jeff Shuren, who spoke during AdvaMed's annual conference, said the heavy coronavirus workload will lead it to miss some MDUFA IV performance metrics.

By Greg Slabodkin • Sept. 28, 2021

FDA starts review after study finds Boston Scientific's Watchman is riskier in women

The agency is working with manufacturers of LAAO devices, a market fought over by Boston Scientific and Abbott, to assess other sources of data before deciding on the next steps.

By Nick Paul Taylor • Updated Sept. 29, 2021

Delta pressure on US hospitals dragged August operations, Kaufman Hall finds

"The August data show we are not out of the woods yet, and hospitals face additional uncertainties as we move into the fall and winter," said Erik Swanson, senior vice president of data and analytics for the consultant group.

By Rebecca Pifer • Sept. 28, 2021

Amid pandemic, medtech R&D, merger activity jumped: EY report

Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.

By Nick Paul Taylor • Sept. 27, 2021

Quarter of providers saw mortality rates rise after ransomware attacks, survey finds

Only 36% of healthcare organizations said they are effective in knowing where all their medical devices are, while just 35% indicated they know when a device's operating system is at end of life or out of date.

By Rebecca Pifer • Sept. 24, 2021

Medtechs face supply chain disruptions from semiconductor shortage: report

The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.

By Nick Paul Taylor • Sept. 24, 2021

Boston Scientific CEO: 'Unprecedented' shutdown from delta to hit Q3

CEO Michael Mahoney cited a six- to seven-week impact from the variant beginning in August, in line with other warnings from medtechs. He said meeting full-year sales estimates is "still possible."

By Ricky Zipp • Sept. 23, 2021

FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event

The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.

By Nick Paul Taylor • Sept. 23, 2021

Medtronic embolization device hit with another Class I recall, 2 deaths cited

The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.

By Susan Kelly • Updated Sept. 22, 2021