Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods

Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.

By Nick Paul Taylor • July 2, 2021

Biden admin 'absolutely supportive' of telehealth once crisis ebbs, Becerra says

The HHS secretary also stressed that, though affordable virtual care should be available to all, the agency would double down to ensure accountability for quality of care.

By Rebecca Pifer • July 1, 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

Roundup: Trial results, looming product releases fuel diabetes tech competition

In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.

June 30, 2021

Medtronic smart insulin pen improved time in target blood glucose levels: study

The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.

By Ricky Zipp • June 29, 2021

Pear secures $400M to scale up digital therapeutic business in SPAC deal

The developer of the first three FDA-authorized prescription digital therapeutics has ambitions to grow sales from a projected $4 million this year to $125 million in 2023.

By Nick Paul Taylor • June 23, 2021

Medicare CGM eligibility widened in potential boon for Abbott, Dexcom

CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.

By Ricky Zipp • June 18, 2021

FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

By Nick Paul Taylor • June 14, 2021

'Covid hangover' to spur health costs to rise 6.5% in 2022, PwC poll predicts

PwC found, however, that a greater reliance on lower-cost sites of care like virtual visits and retail clinics could help offset higher usage of medical services.

By Hailey Mensik • June 9, 2021

Apple unveils new health features aimed at patient-doctor data exchange

The tech giant also announced more in-app information about lab tests without having to run an Internet search, a mobility feature and a respiratory tracker on its devices.

By Rebecca Pifer • June 8, 2021

Cancer tech dominates FDA's latest batch of breakthrough devices

The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.

By Nick Paul Taylor • June 7, 2021

Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott

The results compare favorably to data on Abbott’s Libre 2, further setting the stage for the release of one of the most anticipated new products of 2021 in the diabetes tech market.

By Nick Paul Taylor • June 4, 2021

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

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