Shockwave Medical received a FDA premarket approval for its C2 coronary intravascular lithotripsy-based calcification remedy and announced its 2020 results, in line with expectations.
Shockwave Medical has received US Food and Drug Administration approval for its C2 coronary intravascular lithotripsy (IVL) therapy system.
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Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.
Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.
International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
