Digital Health: Page 21
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Sarah Silbiger via Getty Images
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 -
Eric Thayer via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
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 -
David Paul Morris via Getty Images
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 -
iRhythm Technologies
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 -
Courtesy of Quest Diagnostics
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 -
Deep Dive
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 -
Lintao Zhang / Staff via Getty Images
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 -
Permission granted by iRhythm Technologies
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 -
Sarah Silbiger via Getty Images
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 -
Q&A
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 -
Courtesy of Amazon
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 -
Photography by Gage Skidmore / Photo Illustration by Kendall Davis/MedTech Dive
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 -
Permission granted by iRhythm Technologies
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
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