Former FDA official Abernethy joins Google health spinoff

The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.

By Jonathan Gardner • June 3, 2021

Amid pricing tumult, iRhythm CEO resigns after 4 months in office

After taking over on Jan. 12, Mike Coyle stepped down Tuesday. CFO Douglas Devine will assume the role amid a search for a permanent replacement. Shares were down by nearly 17% Wednesday morning.

By Ricky Zipp • June 2, 2021

Explore the Trendline➔

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

Quest partners with Paige to create AI-enabled cancer pathology products

The two will initially focus on developing regulatory-approved products that support the diagnosis of solid tumors such as cancers of the prostate, breast, colorectal region and lung. 

By Nick Paul Taylor • May 26, 2021

Apple Watch faces ITC probe sparked by AliveCor complaint

The International Trade Commission's inquiry comes in response to allegations that Apple's heart-monitoring technology infringes three of AliveCor's patents.

By Susan Kelly • May 25, 2021

FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief

Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.

By Greg Slabodkin • May 20, 2021

Virtual proctoring, training poised to be new normal in post-pandemic surgical interactions

Prior to the COVID-19 public health crisis, momentum to transition operating rooms into digitally connected learning environments was building. Social distancing mandates accelerated those efforts.  

By Greg Slabodkin • May 19, 2021

OrbiMed, RA Capital top healthcare investors in Q1: CB Insights

OrbiMed topped the list in part because of the investment firm's activity in the medtech industry, where it put money into companies including AnchorDx, Noctrix Health and Adicon.

By Nick Paul Taylor • May 19, 2021

Cue raises $235M to build on point-of-care COVID-19 testing

Updates from Abbott and Quidel suggest the U.S. market for rapid COVID-19 tests has softened in recent months, but the San Diego startup still expanded its investor syndicate to raise its biggest financing round yet.

By Nick Paul Taylor • May 14, 2021

Diabetes tech companies continue 2020's success with Q1 growth. Investors seem unimpressed.

Dexcom, Insulet and Tandem all grew revenue or sales in Q1, winning over Wall Street analysts but seemingly not investors. Meanwhile, the diabetes tech space grows with FDA's clearance of Bigfoot Biomedical's smart insulin pen.

By Ricky Zipp • May 12, 2021

EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems

The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a leading AI role globally.

By Nick Paul Taylor • May 12, 2021

iRhythm again meets with Medicare rate setter after cardiac monitoring pay cut by nearly $200

CEO Michael Coyle said during a Thursday earnings call the company has met with Novitas Solutions to discuss a different pricing methodology. Investors seemed encouraged as shares were up nearly 8% Friday morning.

By Ricky Zipp • May 7, 2021

AI expected to supplant telehealth as top investment priority in next few years, survey finds

Philips' Future Health Index surveying almost 3,000 health leaders worldwide also found a surprising focus on delivering environmentally sustainable healthcare by 2024.

By Rebecca Pifer • May 6, 2021

AI, digital health feature in latest batch of FDA breakthrough device designations

The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.

By Nick Paul Taylor • May 5, 2021

Telehealth use dropped in February for first time since September

The data suggests a potential slowdown in demand for virtual care services that spiked last year in the early months of COVID-19, according to Fair Health's monthly tracker.

By Rebecca Pifer • May 5, 2021

Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions

While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.

By Ricky Zipp • May 3, 2021

Survey casts doubt on utility of wearable devices in healthcare

Forrester's report, based on interviews with doctors, patients and vendors, suggests data gaps and physician skepticism of the popular products is too high for widespread adoption, although design changes could remedy that.

By Ron Shinkman • April 22, 2021

Health funding shatters records in Q1, but medtech a bit of a laggard

Medical device companies were a relative outlier, raising $4.6 billion, down 23% from a peak in the fourth quarter last year, while the number of deals declined by almost 11%, according to a CB Insights report.

By Rebecca Pifer • April 20, 2021

FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

By Nick Paul Taylor • April 16, 2021

iRhythm's future hazy after Medicare pricing saga erases 12-month high

Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.

By Ricky Zipp • April 13, 2021

Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

By Greg Slabodkin • April 12, 2021

iRhythm shares tank after Medicare rates surprise

CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.

By Ricky Zipp • April 12, 2021

Medtronic's robotic spine market lead threatened as smaller rivals look to edge in

Medtronic and Globus Medical are currently in a "two pony race" in the space, but market share can be stolen as other companies launch systems and adoption grows.

By Ricky Zipp • April 9, 2021

Fewer heart tests ordered for telehealth patients in pandemic

Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.

By Susan Kelly • April 6, 2021

Digital health funding hits new high after Q1 rich in megadeals

U.S. digital health companies raised a record $6.7 billion in the first quarter of 2021, putting the industry on track to easily top the $14 billion in investment last year.

By Nick Paul Taylor • April 6, 2021

UCLA engineer calls for mitigation of biases of medical devices

The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.

By Nick Paul Taylor • April 5, 2021