Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology. The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller […]
CMS releases guidance on resuming elective procedures
The Centers for Medicare & Medicaid Services (CMS) issued guidelines for non-emergent, non-COVID-19-related healthcare as facilities reopen. In March, CMS recommended that healthcare providers postpone elective procedures until further notice to preserve personal protective equipment. An April 16 White House recommendation gave the green light for elective surgical procedures to resume. CMS now says, in […]
Nuvaira gains FDA breakthrough nod for lung denervation system
Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device. The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD […]
CMS moves to boost access to Boston Sci’s single-use duodenoscope
Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope. The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide […]
FDA tightens oversight of serological tests for COVID-19
Manufacturers of antibody tests for the COVID-19 virus must now prove the tests’ accuracy to the FDA before they can begin marketing them. And those who do not submit their validation information to the FDA within 10 days may have those tests pulled from the market. The policy reversal follows criticism of the agency’s March […]
White House gives elective procedures green light
Shares of two of the largest orthopedic device companies started climbing this morning on news of a new White House recommendation that elective surgical procedures may resume. Shares of Zimmer Biomet (NYSE:ZBH) were up 6.42% to $116.45 apiece in mid-morning trading and those of Stryker (NYSE:SYK) had risen 5.28% to $184.20.on both an inpatient and outpatient basis […]
Stryker, Boston Scientific changing financial outlook in wake of COVID-19
Stryker (NYSE:SYK) and Boston Scientific (NYSE:BSX) announced that they are withdrawing some of their financial guidance for the first quarter and full-year 2020 amid the COVID-19 pandemic. Originally, Kalamazoo, Mich.-based Stryker reported an expected organic sales growth for 2020 to be in the range of 6.5% to 7.5% and its full-year earnings per share to range between […]
7 ways the coronavirus is affecting medtech
Medtech companies face some tough times as the deadly coronavirus pandemic gains steam. But could this be the medical device industry’s Dunkirk, too? Just days ago, MassMEDIC president Brian Johnson made a call-out on LinkedIn for people to send ideas about how Massachusetts medical device companies could help fight COVID-19. He drew an analogy to […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
CMS considers extending Medicare coverage for heart devices
The Centers for Medicare and Medicaid Services (CMS) may extend coverage for artificial hearts and ventricular assist devices (VADs). Currently, Medicare covers artificial hearts for beneficiaries enrolled in a CMS-approved clinical study, a status that hasn’t been updated since 2008. Artificial heart-maker SynCardia wrote a letter last year to CMS asking it to extend coverage […]
House bill asks CMS to cover breakthrough devices for Medicare patients
U.S. Rep. Suzan DelBene (D-Wash) reintroduced a bill today to improve Medicare patient access to breakthrough medical devices. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) would require Medicare to temporarily cover all devices approved through the FDA’s breakthrough pathway for three years, during which the Centers for Medicare and […]
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