Innovation

Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.

Intuitive Surgical Q2 revenue rises 19% as da Vinci placements surge

The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.
The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.

IPG Photonics bids €300m for Lumibird Medical to build laser platform

IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.
IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.
Digital Health

Kestra Medical secures $200m non-dilutive loan facility with Pharmakon

The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
Biologics

Rani Therapeutics RT-114 oral GLP-1/2 agonist tops subcutaneous exposure

Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Digital Health

KPMG UK leads Black Book 2026 NHS EPR consulting scorecard

Black Book ranked 20 NHS EPR consultants across 620 executive inputs, with KPMG UK/EPR Alliance topping the 18-criterion scorecard at 9.57.
Black Book ranked 20 NHS EPR consultants across 620 executive inputs, with KPMG UK/EPR Alliance topping the 18-criterion scorecard at 9.57.
Biotech

Vilnius University virologist names RNA viruses after Baltic gods

Lithuanian virologist Dr Gytis Dudas has named over a dozen newly discovered RNA viruses after Baltic mythology, folklore and even a heavy metal band.
Lithuanian virologist Dr Gytis Dudas has named over a dozen newly discovered RNA viruses after Baltic mythology, folklore and even a heavy metal band.
Digital Health
Diagnostics

RWS launches integrated eCOA linguistic validation service

RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
Biologics

FDA clears lecanemab subcutaneous autoinjector for Alzheimer's

Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Regulatory Science

Claria Medical wins FDA De Novo clearance for hysterectomy device

The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
Diagnostics
Biologics

Roche wins CE Mark for automated blood test for latent TB

The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
Biologics

Xeltis makes first commercial implant of aXess vascular access device

The Eindhoven medtech has begun its European commercial rollout of aXess, a bioabsorbable hemodialysis graft designed to regenerate into the patient's own living vessel.
The Eindhoven medtech has begun its European commercial rollout of aXess, a bioabsorbable hemodialysis graft designed to regenerate into the patient's own living vessel.
Regulatory Science

Incannex secures US patent for IHL-42X sleep apnoea therapy to 2040

Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Biologics
Bioprocessing

Pluristyx secures Japan patent for synthetic mRNA iPSC reprogramming

The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
Regulatory Science

Cingulate secures first US patent on CTx-1301 ADHD tablet

The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.

FocalTherics launches endometriosis HIFU programme in Europe

FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.
FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.
Digital Health

SHARP launches first health smartwatch using HEALBE FLOW technology

SHARP's Karada Mate Watch integrates HEALBE's bioimpedance-based FLOW platform to estimate calorie intake and hydration automatically.
SHARP's Karada Mate Watch integrates HEALBE's bioimpedance-based FLOW platform to estimate calorie intake and hydration automatically.
Diagnostics

Vilnius University physicists patent pea-sized triplex radiation sensor

A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency
A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency
Biotech

BellaSeno pivotal trial enrols 30 women for absorbable breast scaffold

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
Digital Health

Vibrant Gastro capsule used in JAMA Psychiatry gut-brain study

UCLA researchers used Vibrant's ingestible vibrating capsule to study gut-brain signalling as a predictor of relapse risk in anorexia nervosa recovery.
UCLA researchers used Vibrant's ingestible vibrating capsule to study gut-brain signalling as a predictor of relapse risk in anorexia nervosa recovery.
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