In order to benefit from the Virtual1Care trend, pharma and medtech companies must ensure that their digital health tools, wrapped around a drug or device, comply with evolving regulations.
The company would become part of GE’s ultrasound business, expanding its capabilities to include surgical visualization. GE plans to spin out its healthcare division into a publicly traded company in 2023.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Three life science companies unveiled Series B rounds of funding Thursday, early Christmas gifts that top $219 million combined. Along with Verge Genomics, the other companies that raised new capital are Tasso and Brainomix.
The agency decided to rescind a rule by the previous administration where Medicare would be required to cover breakthrough devices for up to four years after they receive FDA approval or clearance. CMS said it made the change to address safety concerns with the policy.
Johnson & Johnson announced it plans to separate its consumer health products into a separate company, leaving the remaining business to focus on the more research-oriented pharmaceuticals and medical devices business segments. The announcement follows similar moves made by other large pharmaceutical and medical device companies.
General Electric plans to spin out its healthcare business into a publicly traded entity in 2023. It's part of a broader restructuring as the company looks to turn around its business.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Savvy patients. Customer reviews. Increasing choices. It’s easy for medical device brands to view dramatic shifts like these in the market as problems. However, adaptable companies will find that this scenario presents an opportunity to harness the power of quality patient insights for a highly competitive edge.
The webinar on November 18th at 1pm ETwill address considerations around building a personalized connected care solution and how you can achieve it in a very short timeframe.
The proposed rule would allow adults to buy hearing aids without an exam or fitting, with the goal of driving more competitive pricing. Some companies expressed enthusiasm about over-the-counter hearing aids, while industry incumbents were more wary.
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
In July, Dexcom got FDA clearance to allow third parties to access its CGM data. To start, it is integrating with Garmin’s wearable devices.
Judges picked Sonavi Labs as the winner of the home health track at MedCity INVEST Digital Health. The Baltimore-based startup makes a smart stethoscope that can be used at home, and plans to seek FDA clearance for a feature to detect pneumonia.
Medtronic is expanding a recall of two of its MiniMed 600 series insulin pumps after reports found several had broken retainer rings cracked, resulting in insulin doses that were too high or too low.
Diagnostics startup GRIP Molecular is developing an at-home test for Covid-19 and other respiratory infections. The technology builds on advances from several fields, including the discovery of graphene, a material that offers biocompatibility and conductivity.
Medical technology companies saw 288 deals between June 2020 and June 2021, the highest amount ever since Ernst & Young began tracking it in 2007. VC funding in medtech also reached a high point of $9.1 billion.