PAVmed, a medical technology company focused on devices, diagnostics and digital health, and its subsidiary, cancer care platform Veris Health, completed a $2.37 million private placement financing.
Accredited investors acquired PAVmed securities priced at-the-market and shares of Veris common stock indicating a pre-money Veris valuation of almost $35 million.
The financing augments a recently...
The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones.
The guidance, Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations, refers to pulse oximeters intended for medical purposes that are...
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.
"This final guidance is part of the FDA's broader commitment to develop and apply innovative approaches to the regulation of device software functions and contains...
A Saudi-based healthcare startup has successfully raised $1.2 million in its first round of funding, it has been confirmed.
Co-founded last year, HealTec – described as a “dedicated B2B healthcare rehabilitation manufacturing facility” – reportedly facilitates the local production of medical prosthetics and other devices “to serve long-term care and rehabilitation patients.” It secured the...
According to a recent report by international growth partnership company Frost and Sullivan, Western Europe’s medical device market is on track to recover from the COVID-19 pandemic by 2023.
The report, titled ‘Impact of COVID-19 on Elective Procedures in Western Europe, 2020–2023’, projects that the market for selective medical devices for elective procedures will reach $16.8 billion (€13.76B)...
The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic.
According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress.
The regulation entered into force in May 2017, replacing the Medical Devices...
Following its recent departure from the EU, the UK has introduced a new medical device information system (MDIS) that requires all medical devices available on the UK market to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) using official global medical device nomenclature (GMDN).
The new system came into effect on 1 January 2021, with certain devices allowed a...
