Leveraging awareness communications to grasp the potential opportunity for medical devices designed to monitor health and ...

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent ...

MARLBOROUGH, Mass., Jan. 8, 2025 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Bolt Medical, Inc., the developer of an ...

The European Commission’s Green Deal sets specific sustainability targets across the EU, while policies like the German Supply Chain Act (LkSG) of 2023 are setting standards domestically. TÜV SÜD ...

In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives. Arlington, Virginia, Jan. 06, 2025 (GLOBE NEWSWIRE) — ...

Harmony™ Transcatheter Pulmonary Valve system received approval for minimally invasive treatment option for patients with congenital heart disease across European Union. JAN 6, 2025 – Medtronic plc, a ...

According to CDER Director Patrizia Cavazzoni, CDER’s new Center for Real-World Evidence Innovation represents a major step forward in efforts to unlock the full potential of RWD to inform clinical ...

Acquisition expected to strengthen Stryker’s neurovascular business with Inari VTE product portfolio including mechanical thrombectomy solutions for peripheral vascular diseases such as deep vein ...

In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives. Overcoming 21 CFR compliance challenges – stringent ...

Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” ...

Law firm, Hogan Lovells, analyzes the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products.

Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining compliance with regulatory requirements. Life sciences manufacturers are ...