Approvals

Phillips-Medisize expands FDA compliant medical manufacturing capacity to support growing customer needs

Phillips-Medisize, a Molex company, announces the Little Rock, Arkansas facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA.

Orchestra BioMed secures FDA Breakthrough Device designation for Virtue Sirolimus-eluting Balloon

Biomedical innovation company Orchestra BioMed announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for its Virtue Sirolimus-Eluting Balloon (SEB) to treat coronary in-stent restenosis (ISR).

Hill-Rom devices earns U.S. Department of Defense authority to operate

Hill-Rom announced the U.S. Department of Defense (DoD) has granted Conditional Authority to Operate (ATO-C) its Welch AllynConnex monitoring systems (Connex Spot Monitor and Connex Vital Signs Monitor), Connex vital signs connectivity solutions, and the ELI 380 resting ECG (electrocardiograph) device.

BAROnova receives FDA approval for TransPyloric Shuttle (TPS) device

BAROnova announced that the US Food and Drug Administration (FDA) has approved the TransPyloric Shuttle (TPS) Device, a non-surgical weight loss solution for adult individuals suffering from obesity with a body mass index (BMI) of 30 to 40 kg/m2.

FDA approves generic naloxone nasal spray for treating opioid overdose

The US Food and Drug Administration (FDA) has granted approval for the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, to stop or reverse the effect of opioid overdose.

Cutera secures Canada regulatory approval for Secret RF system

Cutera, a provider of laser, light and other energy-based aesthetic systems, announced that Canada’s healthcare regulatory authority Health Canada has granted a Medical Device License for its Secret RF system.

Intact Vascular secures FDA approval for Tack Endovascular System

Intact Vascular, a private medical device company, has received an approval from the US Food and Drug Administration (FDA) for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD).

SI-BONE secures FDA clearance for iFuse Bedrock technology in spinopelvic fixation

Medical device-maker SI-BONE has secured the US Food and Drug Administration’s (FDA) additional 510(k) clearance for use of its iFuse Bedrock technology in fusion of the sacroiliac (SI) joint during long construct procedures.

Why the FDA is re-framing the regulation process for AI-based medical devices

During his final days as the FDA Commissioner, Dr Scott Gottlieb revealed the the agency will consider a new framerowk for AI medical devices regulation