Digital Health: Page 22
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CMS again passes on national pricing for long-term cardiac monitoring, dramatically reduced rates remain
The Physician Fee Schedule proposal continues the seven-month pricing saga that has hung over the cardiac wearables sub-market. Companies like iRhythm now have few options left to get substantially reduced rates increased.
By Ricky Zipp • July 14, 2021 -
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Telehealth use stabilizing at 38 times pre-COVID-19 levels, McKinsey says
Although usage has dropped slightly since its peak in spring 2020, patient and physician attitudes toward telehealth have improved, according to new data from the consultancy.
By Rebecca Pifer Parduhn • July 13, 2021 -
Joe Raedle via Getty Images
Hillrom ordered to complete BardyDx transaction by Delaware court
The court found recent Medicare rate cuts for long-term cardiac wearables did not qualify as a material adverse event, siding with Bardy Diagnostics. However, the judge did not grant BardyDx compensatory damages.
By Ricky Zipp • July 12, 2021 -
Getty Images
MDUFA talks expose 'fundamentally different' views of FDA and device companies
At the latest meeting over user fees, industry remained opposed to the agency's pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA's purview.
By Nick Paul Taylor • July 12, 2021 -
Digital health funding in 2021 smashes last year's record with $14.7B
Coronavirus-spurred momentum in the sector has only accelerated, according to a new Rock Health report.
By Rebecca Pifer Parduhn • July 7, 2021 -
Danielle Ternes/MedTech Dive
Q&ADexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum
Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.
By Ricky Zipp • July 6, 2021 -
Sarah Silbiger via Getty Images
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 -
Retrieved from C-SPAN on February 23, 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 Parduhn • July 1, 2021 -
Kendall Davis/MedTech Dive
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 -
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 Parduhn • 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
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