Category: Medical Devices

August 31, 2023

Ventilator manufacturer Hamilton Medical has launched a voluntary recall of four of its ventilators following reports of software troubles that cause the device to stop working without warning. The products in question assist patients who need full and partial breathing […]

August 16, 2023

Orthopaedic implant company 4WEB Medical has commercially introduced its Cervical Spine Plating Solution (CSTS-PS). The company also intends to broaden its range of cervical products in the fourth quarter of this year, apart from introducing the new cervical plate. This […]

July 11, 2023

Better Therapeutics has received marketing authorisation from the US Food and Drug Administration (FDA) for its prescription-only digital behavioural therapeutic device, AspyreRx. AspyreRx (previously BT-001) is intended for delivering cognitive behavioural therapy to type 2 diabetes (T2D) patients aged 18 […]

July 6, 2023

Medical devices company Biocomposites has acquired a minority stake in UK-based Renovos Biologics, for an undisclosed sum. Renovos has developed a synthetic, biodegradable nanoclay carrier called RENOVITE, which intends to place several pharmaceutical drugs and biologics at the treatment site. […]

July 6, 2023

Patients who require rhythmic assistance in two chambers of the heart now have the option of a leadless system, after the US Food and Drug Administration (FDA) approved Abbott’s AVEIR dual-chamber (DR) leadless pacemaker system. The FDA nod came hot […]

June 28, 2023

The exponential growth of IoT and medical devices across the healthcare sector has increased the attack surface of these organizations. Ransomware attacks continue to grow in volume and scale, with increased impact to connected medical devices, patient care/safety, and exposure […]

June 23, 2023

US-based diabetes-focused medical technology company Beta Bionics has received FDA 510(k) clearance for the compatibility of the Fiasp Pumpcart prefilled insulin cartridge with the iLet automated insulin-delivery system. The iLet is a bionic pancreas that fully automates 100% of all […]

June 21, 2023

Insulet has launched its Omnipod 5 automated insulin delivery system (Omnipod 5) in the UK. Omnipod 5 is indicated for use in type 1 diabetes patients aged two years and above. It can integrate with a continuous glucose monitor to […]

June 19, 2023

Due to higher capital expenditures, the medical robotics industry was more vulnerable to economic headwinds in 2022 than producers of less expensive devices. However, as underlying demand is still very strong, the robotics business will keep growing through 2030. According […]

June 19, 2023

China-based medical equipment company Valgen Medtech presented the 12-month results of the DRAGONFLY-DMR trial during the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2023. DragonFly is a transcatheter-edge-to-edge repair (TEER) therapy that has been successfully implanted in more than 300 […]

June 16, 2023

As razor manufacturers strive to meet the ever-increasing demands of consumers, the choice of razor blade metal plays a pivotal role in ensuring superior performance and durability. One of the key characteristics consumers look for in a razor blade is […]

June 15, 2023

The use and variety of consumer health technology devices has increased dramatically over the past two decades. Scientists at AnalyticsIQ developed a survey to find out how people are incorporating health tech into their lives, asking about 8,000 Americans across […]

June 13, 2023

US-based medical device cybersecurity company MedCrypt has partnered with Stratigos Security to provide security assessments and penetration testing offering a suite of third-party assessment and advisory services. MedCrypt provides security products and services to some of the biggest medical device […]

June 12, 2023

The US Food and Drug Administration (FDA) has issued a press release providing recommendations on how to handle the recent recall of Getinge/Maquet’s oxygenators used for extracorporeal circulation. The move comes after Getinge/Maquet issued an Urgent Medical Device Removal notice […]

June 8, 2023

Lithuanian company Teltonika has initiated mass production of its smart medical wristband for detecting irregularities in heart rhythm. The device called TeltoHeart developed when Kaunas University of Technology scientists, and representatives of Vilnius University, built an algorithm to detect atrial […]

June 1, 2023

Combining MRI imaging technology with artificial intelligence, Ezra scans for possible cancer in the human body in up to 13 organs. It also monitors for hundreds of other conditions, such as brain aneurysms or fatty liver disease. The New York-based […]

May 22, 2023

Beta Bionics has received approval from the US Food and Drug Administration (FDA) for its iLet ACE Pump and iLet Dosing Decision Software to treat people with type 1 diabetes aged six years and above. The pump and the software, […]

May 11, 2023

Medical device labels aim to inform patients and healthcare providers on how to use and maintain instruments, as well as communicating safety or associated risks. As device and diagnostic manufacturers worldwide develop new products to improve patients’ quality of life, […]

May 2, 2023

The regulation of software as a medical device is required to ensure that software used for medical reasons produces accurate, safe, and effective outcomes. A software application that is meant to be used for the diagnosis, treatment, or monitoring of […]

May 1, 2023

Promis Diagnostics has received breakthrough device designation from the US Food and Drug Administration (FDA) for its EarlyTect BCD test. The test is approved for a non-invasive, urine-based diagnosis of bladder cancer from haematuria patients. EarlyTect BCD test will help […]