Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread. Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was […]
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Amazon company gains EUA for COVID test
Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for its real-time PCR test for COVID-19. According to an FDA letter, dated March 25, the test is authorized for the detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individuals 18 or older, including those without […]
BD lands EUA for COVID/flu test
The FDA issued a letter to BD (NYSE:BDX) to confirm the emergency use authorization of its Veritor system for detecting COVID-19 and flu. According to the letter, dated last week, the Veritor system was authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and/or influenza A and B nucleoprotein antigens directly from […]
NeuroPace files for $75M IPO
Refractory focal epilepsy treatment developer NeuroPace last week filed with the SEC to raise up to $75 million in an initial public offering. Mountain View, Calif-based NeuroPace develops the RNS system, which it touts as the world’s only closed-loop brain-responsive neurostimulation system designed to prevent seizures at their source. The RNS system includes a neurostimulator, […]
MedTech 100 roundup: Slight rise for the industry
While medtech’s performance still isn’t mirroring the beginning of 2021, the industry is showing signs of life with a small improvement last week. The year’s strong start, during which MassDevice‘s MedTech 100 index notched an all-time best of 110.96 points (Feb. 15) came to an end later that month and carried over into March, with the […]
DTW Podcast – CEO MacMillan on how COVID-19 strengthened Hologic
Hologic CEO Steve MacMillan says in early March 2020 he didn’t appreciate how COVID-19 would change the world forever. But the diagnostics company quickly rose to the challenge, becoming one of the surer suppliers of diagnostic tests needed to chart the coronavirus’s severity. In this DeviceTalks Weekly podcast, MacMillan shares how Hologic pivoted to meet […]
EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures
Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, […]
Helius Medical wins FDA nod for tongue stimulator that improves MS patients’ gait
The FDA announced today that it authorized marketing for a stimulator device that treats gait deficit in those with multiple sclerosis (MS). Helius Medical’s portable neuromodulation stimulator (PoNS) is a neuromuscular tongue stimulator that uses a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to treat […]
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device […]
How 5G could affect medtech
The latest standard of broadband technology continues to make waves in 2021. But what about medtech? Cellphone using 5G (Imagy by Frederik Lipfert on Unsplash) Wireless tech companies such as Qualcomm are predicting download speeds as high as 10 gigabits per second as next-generation 5G cellular networks roll out worldwide. The open question in medtech is […]
How big medtech fared during a year of COVID-19
Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing/MassDevice analysis of financials. Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against […]