iRhythm doesn't expect 2022 CMS pricing. 'It may take some time.'

Amid a challenging 2021, the cardiac monitoring player beat Wall Street revenue expectations. However, Medicare pricing uncertainty is still hanging over its future.

By Ricky Zipp • Aug. 6, 2021

Digital health, heart disease devices feature in latest FDA breakthrough designations

Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.

By Nick Paul Taylor • Aug. 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

Hillrom reverses course, will finalize $375M BardyDx acquisition

The decision ends a months-long fight by Hillrom to back out of the buy due to substantially reduced Medicare rate cuts for long-term cardiac monitoring. Hillrom expects the deal to close in the coming weeks.

By Ricky Zipp • Aug. 2, 2021

GE Healthcare's COVID-19 recovery continues with double-digit growth in imaging, ultrasound

Second-quarter results reflect the return of elective procedures to pre-pandemic levels. A standout was its pharmaceutical diagnostics business which saw orders grow nearly 50% organically year over year.   

By Greg Slabodkin • July 27, 2021

Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

By Nick Paul Taylor • July 26, 2021

Health tracking tech revenue to reach $13B this year amid sustained consumer demand

Devices like blood glucose trackers, smart thermometers and pulse oximeters are a small but growing slice of the larger consumer tech market, according to the Consumer Technology Association.

By Rebecca Pifer • July 19, 2021

Dexcom wins FDA nod for real-time APIs, allowing third-party developers access to CGM data

Teladoc Health's Livongo and smartwatch maker Garmin are in the testing and development phase, Dexcom said. The clearance comes as FDA is working to address the devices backlog created by the pandemic.

By Ricky Zipp • July 16, 2021

CMS proposes extension of Medicare telehealth coverage

Provider groups are not happy with the payment adjustment in the rule — a 3.75% reduction to the conversion factor due to budget neutrality requirements — and will likely seek congressional intervention.

By Shannon Muchmore • July 14, 2021

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

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 • July 13, 2021

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

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 • July 7, 2021

Dexcom 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

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

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