Satsuma Pharmaceuticals has raised $62 million in a Series B preferred stock financing, led by Wellington Management Company. Other existing investors in this Series B funding included RA Capital Management, TPG Biotech and Shin Nippon Biomedical. Osage University Partners, CAM Capital, Surveyor, Eventide Asset Management, Cormorant, Lumira Ventures and SBI Investment were new investors. Get the […]
Alvogen recalls fentanyl patches over 3M labeling error
Alvogen announced that it is voluntarily recalling two of its Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level because of a labeling issue. The company says that a small number of cartons that were labeled as 12 mcg/h Fentanyl Transdermal System patches actually had 50 mcg/h patches. The 50 mcg/h patches in the […]
FDA clears generic Narcan nasal spray
The FDA announced today that it has approved the first generic naloxone hydrochloride nasal spray, a life-saving medication that is designed to stop or reverse opioid overdose effects. The FDA also said that it is planning new steps to prioritize the review of other generic drug applications that treat opioid overdose. Nearly 400,000 people have […]
Johnson & Johnson announces Women in STEM2D winners
Johnson & Johnson recently announced six winners for its 2019 Women in STEM2D Scholars Award. Each winner will receive $150,000 in funding and three years of mentorship from the company. Johnson & Johnson launched its Women in STEM2D (WiSTEM2D) Scholars Award in 2017 to encourage the development of female STEM2D leaders by awarding and sponsoring […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
Egypt fast-track medical device registration pathway speeds up market access timeframes
By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com […]
Penumbra VR device wins FDA clearance
Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the […]
FDA clears Gelesis weight-loss hydrogel pill Plenity
Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug. The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without […]
U.K. government requests Brexit deadline extension
By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown
By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions […]
5 issues for medical device risk management and design controls
By Mark Leimbeck, Emergo Group Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Get the full story here at […]
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