MIVI seeks FDA clearance for stroke catheter as trial meets primary endpoint
According to a report on GlobalData’s Pharma Intelligence Center, the ischemic stroke market is forecast to be worth $10.6bn in the eight major markets in 2027. Credit: mi_viri via Shutterstock. MIVI Neuroscience has submitted data to the US Food and Drug Administration (FDA) for clearance of its Q Revascularization System as the company’s EvaQ acute […]
Another recall: does Philips have a quality control problem?
Philips has recalled a number of high-profile medical devices in recent years, raising questions about its quality control. Photo: Sem van der Wal/ANP/AFP. Multinational electronics and medical device manufacturer Philips has made headlines lately for all the wrong reasons. The recent recall of its SPECT BrightView nuclear imaging system is the latest in a series […]
Exactech and Statera partner to develop smart reverse shoulder implant
The Exactech and Statera’s smart implant is expected to help surgeons objectively quantify a patient’s soft tissue tension and adjust the ideal implant offset and size for a particular patient. Image Credit: joel bubble ben / Shutterstock. US-based Exactech is partnering with Canadian medical device developer Statera Medical to design the world’s first smart reverse […]
Visby Medical launches gonorrhoea test with antimicrobial resistance check
The Boston-based company was awarded the money by CARB-X to develop the portable rapid polymerase chain reaction (PCR) test designed to identify gonorrhoea. Credit: Shutterstock / Kateryna Kon A US sexual health diagnostic firm, Visby Medical, has been granted $1.8m to develop a portable rapid diagnostic for gonorrhoea that includes tests for antibiotic susceptibility. The […]
Biotronik launches Micro Rx catheter in US
Biotronik plans to launch the Micro Rx catheter in Canada next month. Credit: BIOTRONIK SE & Co. KG. Biotronik has launched the Micro Rx catheter, a new device for enhancing guidewire support during percutaneous coronary interventions (PCI), in the US. The rapid exchange microcatheter is produced by Interventional Medical Device Solutions (IMDS) and exclusively distributed by […]
Widex launches SmartRIC device for natural hearing
The Widex SmartRIC features new microphone inlets to reduce wind and touch noise. Credit: PRNewswire/ Widex. Widex has launched the Widex SmartRIC hearing aid, a device designed to enhance natural hearing. The L-shaped design of the device positions the microphones to better capture speech and align with the wearer’s listening focus. Said to be Widex’s […]
GE HealthCare, MedQuest collaborate to enhance outpatient imaging
The strategic move is expected to enhance operational efficiency and patient care quality in outpatient imaging. Credit: raker/ shutterstock.com. GE HealthCare has announced a three-year collaboration with MedQuest Associates to provide new medical device technology and digital tools for outpatient imaging centres. The partnership aims to optimise multi-site outpatient imaging networks and improve patient care […]
IntuiTap’s VerTouch device secures US FDA clearance
IntuiTap CEO Jessica Traver. Credit: Business Wire/IntuiTap Medical. IntuiTap Medical has received approval from the US Food and Drug Administration (FDA) for its handheld imaging tool, VerTouch, designed to enhance the accuracy and consistency of spinal punctures. This clearance validates the new device’s safety and effectiveness. VerTouch can assist healthcare providers in performing spinal punctures […]
Healthcare app regulators are adapting to increased activity
Apps are powerful tools that particularly help patients with routine behaviour. Credit: Koshiro K via Shutterstock. Two very distinct types of apps focus on healthcare: the nebulous wellness category and regulated digital therapeutics. This divide is due to national regulatory bodies such as the US Food and Drug Administration (FDA) that oversee the approval of […]
RevUp remote patient monitoring technology cuts hospital readmission by 50%
Patients monitored using RevUp for one year saw a 19% readmission rate and 30% for patients not enrolled in the trial. Credit: Shutterstock / Maria Symchych. A study sponsored by digital health provider MD Revolution has found that remote patient monitoring systems can be used to cut 30-day cardiovascular readmissions by half. The study was […]