Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

GE unveils plan to spin off healthcare business

The independent company, expected to be separated by early 2023, is being positioned as having more flexibility to pursue acquisitions as it sharpens its focus on precision health and struggles with supply chain shortages.

By Susan Kelly • Nov. 10, 2021

CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

By Nick Paul Taylor • Updated Nov. 12, 2021

Philips grows cardiac monitoring business with Cardiologs pickup

Nearly one year after announcing its $2.8 billion acquisition of BioTelemetry, the Dutch conglomerate is further expanding its reach in remote patient monitoring with the purchase of France-based Cardiologs.

By Susan Kelly • Nov. 9, 2021

CMS finalizes plans for pay cuts for radiation oncology, other specialists

Device makers could feel the pinch in cuts to services that use pricey equipment for vascular surgery, interventional radiology and diagnostic testing, which AdvaMed contends will decrease patient access to care.

By Shannon Muchmore • Nov. 3, 2021

Thermo Fisher, Hologic ride wave of COVID-19 test demand, for now

The two lateral flow assay companies reported strong coronavirus testing sales in the latest quarter. However, Hologic CFO Karleen Oberton told investors late Monday the pandemic remains unpredictable.

By Greg Slabodkin • Nov. 2, 2021

Siemens' Varian leads latest FDA breakthrough device designations

Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

By Nick Paul Taylor • Nov. 1, 2021

FDA, global peers create guiding principles for AI/ML medical devices

The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.

By Nick Paul Taylor • Oct. 29, 2021

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.

By Nick Paul Taylor • Oct. 27, 2021

Notified bodies join chorus of criticism of proposed European AI regs

Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.

By Nick Paul Taylor • Oct. 26, 2021

Amazon teases 5 more cities to get virtual Amazon Care offering this year

Amazon Care is currently live in the Washington, D.C. and Baltimore area, and will be rolled out in Dallas, Chicago, Philadelphia, Boston and Los Angeles this year, the unit's director told the HLTH conference this week.

By Rebecca Pifer • Oct. 22, 2021

Abbott, Intuitive, J&J set tone for earnings: Testing up, procedures down

The medtechs in recent days confirmed the mixed financial impact of the delta wave and early signs of recovery in elective procedures in the U.S. Reports from Boston Scientific and Stryker come next week.

By Nick Paul Taylor • Oct. 21, 2021

Abbott COVID-19 sales rebound, but calls market too volatile for 2022 forecast

CEO Robert Ford warned investors that despite a big uptick driven by the delta surge, "we'll have to update on a rolling quarterly basis."    

By Greg Slabodkin • Oct. 20, 2021

In last ditch plea to save MCIT, medtech groups suggest fixes to CMS

AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.

By Nick Paul Taylor • Oct. 20, 2021

Abbott software causing COVID-19 test false positives, starts Class I recall fix

FDA said use of the tests before the problem is corrected may cause serious adverse health consequences or death, alerting laboratories to treat the results as presumptive and that they may need to be confirmed with another test.

By Nick Paul Taylor • Oct. 19, 2021

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

The EC's proposal creates a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.  

By Nick Paul Taylor • Oct. 15, 2021

Medtronic pledges R&D boost, brand refresh, amid rising Big Tech rivalry

CEO Geoff Martha said the device giant is still "building out that direct-to-consumer muscle" and acknowledged "healthy competition" with the likes of Apple and Google.

By Greg Slabodkin • Oct. 14, 2021

EU proposes to delay IVD Medical Device Regulation, citing COVID-19 backlog

Originally set to go into effect in May 2022, a progressive rollout is now planned. The proposal will now go to the European Parliament and Council for adoption, according to the announcement.

By Kim Dixon • Updated Oct. 14, 2021

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.

By Nick Paul Taylor • Oct. 12, 2021

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.

By Nick Paul Taylor • Oct. 11, 2021

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."

By Greg Slabodkin • Oct. 8, 2021

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.  

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

FDA labels Ellume's recent COVID-19 Home Test recall Class I event

The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

By Nick Paul Taylor • Updated Nov. 10, 2021

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.

By Nick Paul Taylor • Oct. 5, 2021