Boston Scientific, Zimmer Q2 expectations lifted by Abbott, J&J, Intuitive results

Second-quarter results from Abbott Laboratories, J&J and Intuitive Surgical offer encouragement for the rest of the medtech reporting season, according to BofA Securities analysts. They also expect a "small beat" for Dexcom. 

By Nick Paul Taylor • July 26, 2021

Growing cyberattacks on hospitals may soon hit bottom lines, patient care: Fitch

The increased use of smart monitoring devices, telehealth and other virtual care capabilities are putting patient data at risk, the report said. CT scanners and MRI machines were not necessarily designed with "cyber risk in mind."

By Ron Shinkman • July 26, 2021

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

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

FDA labels Philips sleep apnea, ventilator recall Class I, ResMed eyes advantage

The agency notices come about one month after Philips announced the recall and began pulling machines from the market. Rival ResMed said there has been a "considerable increase in demand" for its products since the recall.

By Ricky Zipp • Updated July 23, 2021

CDRH still digging out of backlog caused by COVID-19: Shuren

"We think it's more important to focus on the submissions we already have in house than to talk about products yet to come before us," the device center chief said. "Hopefully, sometime in 2022 we'll get back on track."

By Ricky Zipp • July 22, 2021

Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics

While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.

By Greg Slabodkin • July 22, 2021

FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

By Nick Paul Taylor • July 22, 2021

Intuitive's Q2 robot placements accelerate amid procedure recovery

While the robotic surgery leader is eyeing the delta variant for potential to curb demand, the company raised its forecast for procedure growth this year. However, the outlook does not reflect significant disruptions.

By Susan Kelly • July 21, 2021

J&J medical device sales return to pre-pandemic levels in Q2 as COVID-19 impact wanes

The company's return to growth, fueled by the recovery of elective volumes, could signal where procedure-dependent medtechs stand as the industry recovers from the effects of the coronavirus.

By Ricky Zipp • July 21, 2021

Radiation therapy 'under attack' from CMS cuts, professional body warns

Equipment manufacturers including Varian, ViewRay, Hitachi, Siemens and Elekta are among those that could also be affected by the reimbursement changes.

By Nick Paul Taylor • July 21, 2021

Medtech funding surges with early-stage deals

Robot company CMR Surgical, portable dialysis system maker Quanta Dialysis Technologies and diabetes technology developers were among the biggest recipients of private financing in the second quarter.

By Susan Kelly • July 20, 2021

CMS pitches stiffening price transparency fines, halting end of inpatient-only list

The proposed rule moves hundreds of procedures back to hospitals and reverses a Trump-era regulation that attempted to phase out the inpatient-only list. An ASC representative called the regulatory back-and-forth "jarring."

By Shannon Muchmore • July 20, 2021

Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target

The agency's OK for the spinal cord stimulation device potentially opens a market worth billions of dollars. For now, though, preliminary quarterly revenue came in below its prior forecast.

By Nick Paul Taylor • July 20, 2021

Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers

Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.

By Nick Paul Taylor • July 19, 2021

Digital medicine coding keeps pace with innovation

As digital medicine continues to expand and take on a more prominent role in patient care, the CPT® code set continues to provide the coding infrastructure needed to successfully integrate new technology into clinical practice. 

By Jenny Querry • July 19, 2021

Medtech M&A expected to be robust in second half after 2021 began with a flurry

Even after deals already eclipsed last year's numbers, analysts predict robust activity in particular among diagnostics companies flush with cash from 2020's COVID-19 test sales.

By Ricky Zipp • July 18, 2021

NuVasive's scoliosis system gets reinstated CE mark, new instructions for use

FDA said in a Friday safety communication that NuVasive has also lifted a shipping hold for MAGEC systems outside of the U.S. The company lifted a U.S. shipping hold in July.

By Nick Paul Taylor , Ricky Zipp • Updated Dec. 13, 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

Kiwa Cermet Italia becomes 21st notified body under MDR amid capacity concerns

It is the first new NB since May's date of application and the fourth organization to be designated this year. But, MedTech Europe has warned about limited certification capacity as thousands of certificates are set to expire before 2024.

By Nick Paul Taylor • July 15, 2021

Transmedics wins premarket approval for OCS liver system, adding to recent FDA nods

The company was granted premarket approval for the OCS heart system and 510(k) clearance for the OCS lung solution. Transmedics' stock price was up over 6% following the Wednesday announcement.

By Nick Paul Taylor • Updated Sept. 29, 2021

Pacemaker implantation after aortic valve replacement linked to mortality risk

A large cohort study found pacemaker recipients had significantly higher rates of mortality and heart failure hospitalization. The authors said the risk is an important consideration for transcatheter procedures in younger patients.

By Nick Paul Taylor • 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

TransMedics stock halted in Nasdaq trading ahead of FDA advisory panel meeting

The company's stock price was down more than 5% at the close of trading on Tuesday. An FDA panel on Wednesday is evaluating data concerning the safety and effectiveness of TransMedics' device for preserving donor livers.

By Nick Paul Taylor • Updated July 14, 2021

Medtech pay to doctors plunged in 2020 as COVID-19 pummeled electives, in-person services fell

Zimmer Biomet had the biggest drop, cutting general payments nearly 80% to $63 million. Other notable decreases include Stryker, J&J's DePuy Synthes and Boston Scientific.

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