Innovation

Biologics
Biotech

Eascra Biotech wins $7.96m NASA contract for space-made nanomedicine

The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
Diagnostics
Digital Health

Heartflow FFRCT cuts unnecessary heart catheterisations by 44%

Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Diagnostics

Philips and Imricor launch combined cardiac iMR lab solution

The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.
The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.
Regulatory Science

FDA grants ZYN nicotine pouches modified risk tobacco status

Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing
Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing
Digital Health
Diagnostics

Trimedx adds agentic AI to TMX Protect to cut device cyber remediation

Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Digital Health
Biotech

Big Digital Energy signs LOI for 17 MW AI campus in Texas

Big Digital Energy's joint venture has signed a non-binding letter of intent with Tensor IQ to develop a 17 MW AI and HPC
Big Digital Energy's joint venture has signed a non-binding letter of intent with Tensor IQ to develop a 17 MW AI and HPC
Diagnostics

Femasys brings FemaSeed portfolio to UNC Health OB/GYN network

Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Biologics

Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse

Nuwellis signs co-promotion deal with Atrility for AtriAmp device

Nuwellis will co-promote Atrility's FDA-cleared cardiac pacing monitor across 14 US states, with an option to become exclusive national distributor.
Nuwellis will co-promote Atrility's FDA-cleared cardiac pacing monitor across 14 US states, with an option to become exclusive national distributor.
Biotech

UK robotics hits $258M in 2026 YTD funding; Cambridge leads all-time

Tracxn data show UK consumer robotics attracted $258M year-to-date in 2026, with Cambridge accounting for nearly 60% of all-time funding at $1
Tracxn data show UK consumer robotics attracted $258M year-to-date in 2026, with Cambridge accounting for nearly 60% of all-time funding at $1
Regulatory Science

Femasys wins FDA modular PMA pathway for FemBloc birth control device

The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.
The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.
Biologics

Vascudyne bioengineered coronary graft sustains 18-month patency

Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.
Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.
Diagnostics
Regulatory Science

FDA clears Vitestro's Aletta robotic blood draw device via De Novo

The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.
The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.
Diagnostics

TearCare wins FDA label update to improve meibomian gland function

Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.
Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.
Digital Health

Vituity CEO says hiring alone won't fix physician burnout crisis

Imamu Tomlinson, CEO of the $2.6bn physician-owned partnership, argues burnout is a systemic failure, not an individual one.
Imamu Tomlinson, CEO of the $2.6bn physician-owned partnership, argues burnout is a systemic failure, not an individual one.
Biotech
Digital Health
Bioinformatics

UK AI funding hits $9.6bn in H1 2026, up 360% year on year

Tracxn data shows five companies absorbed 84% of capital raised, with London capturing 98% of the national total.
Tracxn data shows five companies absorbed 84% of capital raised, with London capturing 98% of the national total.
Bioinformatics

Deep Origin claims 100-fold hit rate gain with DODock screening tool

Deep Origin's physics-augmented virtual screening framework achieved a 30.6% hit rate on CD73, against a 0.3% baseline from a prior AI
Deep Origin's physics-augmented virtual screening framework achieved a 30.6% hit rate on CD73, against a 0.3% baseline from a prior AI
Biologics

MiNK Therapeutics reports Day 28 survival data from agenT-797 Phase 2

Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.
Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.
Diagnostics

Senseonics raises CGM revenue guidance after 120% Q2 growth

Senseonics lifted its full-year 2026 revenue target to $62–66 million after record quarterly revenue and gross margins beat its own guided range.
Senseonics lifted its full-year 2026 revenue target to $62–66 million after record quarterly revenue and gross margins beat its own guided range.

Sight Sciences wins Aetna coverage for OMNI and SION glaucoma systems

Aetna has recognised both implant-free MIGS devices as medically necessary for mild-to-moderate open-angle glaucoma, completing major US payer coverage for Sight
Aetna has recognised both implant-free MIGS devices as medically necessary for mild-to-moderate open-angle glaucoma, completing major US payer coverage for Sight
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