Novasys Medical is using radio frequency (RF) energy to treat stress urinary incontinence in women. The company chose to adopt a much more rigorous and expensive clinical trials strategy than was needed to gain FDA approval of its device. This approach flummoxed the FDA,, slowing approval of the company's IRenessaI system. Novasys is betting that the enhanced data collected from its clinical study will result in the company gaining faster reimbursement that it hopes will drive adoption.
by Stephen Levin
Nowhere has the current increased concern of regulators and industry about the long-term safety of medical devices been reflected more...
Join thousands of industry professionals who rely on In Vivo for daily insights
Already a subscriber?
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.
In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.
Trojan Bio’s proprietary platform, based on engineered antibodies that activate the immune system to fight cancer in the same way as common viral infections, won Biomed Israel's 2025 biopharma start-up award. CEO and cofounder Anat Burkovitz said the technology is attracting investors' attention.
Aneesh Karatt-Vellatt is leading the charge to redefine how ion channels and G protein-coupled receptors (GPCRs) are targeted with antibody therapies, one of the most notoriously challenging classes of drug targets.
In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.
New report by global law firm Taylor Wessing and Bayes Business School forecasts a steadily increasing volume of major life sciences M&A in the coming five years, but highlights concerns over cybersecurity and unrealistic valuations. Taylor Wessing partner Andrew Edge spoke to In Vivo.
