https://www.bioworld.com/rss en-us Med-tech M&A value through the first five months of 2026 reached $62.98 billion, the highest total for the period since 2022’s $84.13 billion and a dramatic step up from 2025’s $22.4 billion and 2024’s $21.86 billion over the same stretch. http://www.bioworld.com/articles/731922 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731922-boston-sci-mirus-pact-lifts-med-tech-dealmaking-to-record-45b-in-may Boston Scientific signage Credit: Boston Scientific Corp. For the long-term impact of GLP-1 therapies in obesity to be realized, they must be paired with data and digital tools. While the drugs are effective, challenges are well known, such as loss of muscle mass loss, compliance and accessibility. With more treatments moving through the pipeline, innovation and technology will be key to supporting long-term use, delegates heard at the HLTH Europe conference in Amsterdam on June 17. http://www.bioworld.com/articles/731908 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731908-glp-1s-need-technologies-for-long-term-use Wireframe of feet and scale Liability remains one of the biggest barriers to the adoption of AI in healthcare. As more tools get developed for use in clinical settings, a key question persists: Who is ultimately at fault when something goes wrong – the hospital, the clinician or the developer? That uncertainty is making clinicians hesitant to adopt new technologies, delegates heard at the HLTH Europe conference in Amsterdam on June 16. http://www.bioworld.com/articles/731892 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731892-hlth-europe-panel-on-ai-liability-in-healthcare-who-is-responsible Doctor, tablet and medical holograms The EMA’s 2025 annual report highlights the pressure it is under to streamline and simplify assessment processes, and the expanded – and explicit – role the agency now has in boosting the competitive position of the EU in the development and manufacturing of drugs. http://www.bioworld.com/articles/731891 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731891-2025-annual-report-reflects-the-changing-role-of-ema EMA report cover Even though children make up a quarter of the population, healthcare technologies are not often designed with them in mind. Investment in pediatric innovation remains limited with investors often viewing returns in the space as less predictable. Nevertheless, a number of companies are looking to address this and are developing technologies for kids. Afterall, with huge investments going into longevity R&D, there is a compelling case for addressing health issues at the very early stage, delegates heard at the first annual Pediatric Innovation Summit, held as part of the HLTH Europe conference in Amsterdam on June 15. http://www.bioworld.com/articles/731875 Mon, 15 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731875-children-overlooked-as-pediatric-innovation-struggles-for-funding Pediatric exam Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions. http://www.bioworld.com/articles/731800 Thu, 11 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731800-dermasensor-receives-ce-mark-for-skin-cancer-detection-device Dermasensor device Dermasensor's skin cancer detection device. Credit: Dermasensor Inc. Total med-tech financing through the first five months of 2026 reached $11.01 billion, falling between 2024’s $12.76 billion and 2023’s $8.95 billion over the same period, and trailing 2025’s $14.83 billion. http://www.bioworld.com/articles/731709 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731709-med-tech-ipo-window-holds-with-151b-raised-through-may-in-2026 Business, data, dollars illustration Dexcom Inc. and Insulet Corp. reported new clinical trial data on their diabetes technologies at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans, offering insights that could aid in clinical adoption. Abbott Laboratories, meanwhile, highlighted the risks of diabetic ketoacidosis (DKA) and presented data showing the growing challenge of identifying DKA as it can develop quickly and mimic common illnesses. http://www.bioworld.com/articles/731707 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731707-pumps-patches-and-fixes-at-the-ada Dexcom G7 CGM Dexcom Inc.’s G7 continuous glucose monitoring system. Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic Republic of Congo and Uganda. The test comes as commentary in The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus. The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus.]]> http://www.bioworld.com/articles/731630 Fri, 05 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731630-roche-develops-pcr-test-to-detect-the-ebola-bundibugyo-virus Swab sample and patient Mammogen Inc. raised $30 million in equity financing in a series A round to support the clinical advancement and commercialization of its RNA-powered molecular diagnostics platform. The company’s lead product is Gentru-breast, a blood-based assay designed to detect molecular signatures associated with breast cancer from a simple blood draw. http://www.bioworld.com/articles/731541 Wed, 03 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731541-mammogen-raises-30m-for-blood-based-breast-cancer-detection-assay Dollar sign between hands IMU Biosciences Ltd. has closed its series A at £40 million (US$53.9 million), adding £28.5 million to the initial close in January 2024, and bringing the total raised since the company’s formation in 2021 to £45 million. Since that first close, IMU has built what is claimed as the world’s largest high-definition immune system dataset, with almost 25,000 profiles of healthy volunteers and disease-specific patient cohorts. http://www.bioworld.com/articles/731669 Wed, 03 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731669-imus-53m-series-a-to-advance-high-definition-immune-profiling-tech Pound sign on tech background Rather than reinventing the wheel for every gene therapy that uses genome editing, the U.S. FDA is advising sponsors on leveraging existing knowledge, be it publicly available or platform-based, to more efficiently advance their products across multiple stages of development. http://www.bioworld.com/articles/731529 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731529-fda-advises-leveraging-whats-already-known-in-gene-therapy-r-and-d DNA double helix illustration with section being removed in red IMU Biosciences Ltd. has closed its series A at £40 million (US$53.9 million), adding £28.5 million to the initial close in January 2024, and bringing the total raised since the company’s formation in 2021 to £45 million. Since that first close, IMU has built what is claimed as the world’s largest high-definition immune system dataset, with almost 25,000 profiles of healthy volunteers and disease-specific patient cohorts. http://www.bioworld.com/articles/731528 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731528-imus-53m-series-a-to-advance-high-definition-immune-profiling-tech Pound sign on tech background The Trump administration’s efforts to ensure U.S. federal grants align with its policies may soon be coming to fruition. The White House Office of Management and Budget released a proposed rulemaking to revise its Guidance for Federal Financial Assistance. http://www.bioworld.com/articles/731514 Mon, 01 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731514-policy-aka-politics-to-have-bigger-role-in-us-grants Gold dollar sign and gray question marks Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis. http://www.bioworld.com/articles/731441 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731441-abbott-receives-ce-mark-for-dual-glucose-ketone-sensing-systems Abbott Libre Duo sensor on patient  Libre Duo sensor. Credit: Abbott Laboratories Conexeu Sciences Inc. has launched a preclinical development program for B.R.E.A.S.T. (Bio-Regenerative Ergonomically Architected Smart Tissue), its 3D-printed bioregenerative breast matrix, at the Wake Forest Institute for Regenerative Medicine (WFIRM), a leading regenerative medicine research organization. Conexeu Sciences Inc. has launched a preclinical development program for B.R.E.A.S.T. (Bio-Regenerative Ergonomically Architected Smart Tissue), its 3D-printed bioregenerative breast matrix, at the Wake Forest Institute for Regenerative Medicine (WFIRM), a leading regenerative medicine research organization.

]]> http://www.bioworld.com/articles/731479 Thu, 28 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731479-conexeu-sciences-launches-preclinical-program-for-bioregenerative-breast-matrix Digital rendering of molecular structures Insulet Corp. has initiated a voluntary medical device correction affecting insulin pump pods in its Omnipod product lines after discovering a manufacturing issue that could lead to the leaking of insulin and the under-delivery of doses in some patients. The company said that some pods from specific lots may have a small tear in the cannula. http://www.bioworld.com/articles/731419 Wed, 27 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731419-insulet-initiates-voluntary-correction-on-omnipod-devices Omnipod 5 Omnipod 5. Credit: Insulet Corp. Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20. http://www.bioworld.com/articles/731471 Tue, 26 May 2026 11:00:00 -0400 https://www.bioworld.com/articles/731471-ai-remote-care-drive-new-models-for-australian-medtech Ausbiotech panel - Tracy-Duffy (far left) The TGA’s Tracy Duffy (far left) explains the agency’s thinking about regulating AI-based devices during the 2026 Ausmedtech conference in Perth. Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20. http://www.bioworld.com/articles/731375 Thu, 21 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731375-ai-remote-care-drive-new-models-for-australian-medtech Ausbiotech panel - Tracy-Duffy (far left) The TGA’s Tracy Duffy (far left) explains the agency’s thinking about regulating AI-based devices during the 2026 Ausmedtech conference in Perth. It is not surprising that a large Ebola outbreak would be considered a public health emergency of international concern. But the current PHEIC is notable for the speed with which it was declared, speaking to the urgency of the situation. World Health Organization Director-General Tedros Adhanom Ghebreyesus declared the outbreak a PHEIC on Sunday, May 17, without first convening an emergency committee. That step is unprecedented. http://www.bioworld.com/articles/731400 Thu, 21 May 2026 10:00:00 -0400 https://www.bioworld.com/articles/731400-sizing-up-an-epidemic-with-diagnostics-and-bioinformatics WHO response to Ebola outbreak in DRC WHO mobilized emergency supplies in response to the ongoing Ebola outbreak in the Democratic Republic of the Congo from the WHO Emergency Preparedness and Response Hub warehouse in Nairobi, Kenya. Credit: WHO As interests and competition in the intravascular lithotripsy (IVL) market heats up, Shockwave Medical Inc. said it believes that its latest coronary IVL catheter, the C2 Aero, and other projects in the pipeline, will help it to maintain its leadership in calcium modification. http://www.bioworld.com/articles/731372 Thu, 21 May 2026 08:00:00 -0400 https://www.bioworld.com/articles/731372-as-ivl-technologies-advance-shockwave-looks-to-defend-its-lead Shockwave Medical - C2 Aero coronary IVL C2 Aero coronary IVL catheter. Credit: Shockwave Medical Inc. The short story of the U.S. Court of Appeals for the Federal Circuit’s May 19 opinion in Recor Medical Inc. v. Medtronic Ireland is that the lower court got it wrong when it ruled Medtronic lacked the required standing to bring an infringement countersuit against Recor because it had granted an exclusive license for products covered by the two asserted patents. The case was reversed and remanded. Recor Medical Inc. v. Medtronic Ireland is that the lower court got it wrong when it ruled Medtronic lacked the required standing to bring an infringement countersuit against Recor because it had granted an exclusive license for products covered by the two asserted patents. The case was reversed and remanded.]]> http://www.bioworld.com/articles/731345 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731345-us-fed-circuit-clarifies-standing-in-the-face-of-licensures A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris. http://www.bioworld.com/articles/731344 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731344-subgroup-analysis-of-the-champion-af-trial-shows-age-not-a-factor Boston Scientific Watchman FLX Watchman FLX left atrial appendage closure device. Credit: Boston Scientific Corp. It is not surprising that a large Ebola outbreak would be considered a public health emergency of international concern. But the current PHEIC is notable for the speed with which it was declared, speaking to the urgency of the situation. World Health Organization Director-General Tedros Adhanom Ghebreyesus declared the outbreak a PHEIC on Sunday, May 17, without first convening an emergency committee. That step is unprecedented. It is not surprising that a large Ebola outbreak would be considered a public health emergency of international concern. But the current PHEIC is notable for the speed with which it was declared, speaking to the urgency of the situation. World Health Organization Director-General Tedros Adhanom Ghebreyesus declared the outbreak a PHEIC on Sunday, May 17, without first convening an emergency committee. That step is unprecedented.

]]> http://www.bioworld.com/articles/731343 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731343-sizing-up-an-epidemic-with-diagnostics-and-bioinformatics WHO response to Ebola outbreak in DRC WHO mobilized emergency supplies in response to the ongoing Ebola outbreak in the Democratic Republic of the Congo from the WHO Emergency Preparedness and Response Hub warehouse in Nairobi, Kenya. Credit: WHO The evolution of cancer diagnostics continues with the FDA’s May 20 approval of Guardant Health Inc.’s Guardant360 Liquid cDx. The new blood-based comprehensive genomic test assesses a 100-times wider genomic footprint than the previously approved Guardant360 cDx to deliver comprehensive tumor profiling results, according to the company. It noted that the seven companion diagnostic indications already approved for the older test will transfer to the new one. http://www.bioworld.com/articles/731342 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731342-fda-approval-advances-personalized-cancer-diagnostics Guardant360 Liquid cDx Guardant360 Liquid cDx. Credit: Guardant Health Inc. Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women. http://www.bioworld.com/articles/731340 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731340-all-women-data-show-allegra-edge-in-female-tavr-patients Biosensors International Allegra transcatheter heart valve Allegra transcatheter heart valve. Credit: Biosensors International The convergence of robotics, sensors and AI is reshaping how medical devices interact with patients, clinicians and healthcare systems. Across the field, from oncology to cardiology and women’s health, companies are integrating software, connectivity, data analytics and biological information into their products. And although traditional devices, such as screws for orthopedics or valves for cardiology, remain essential, the shift underway is leading to much more personalized medicine, which is more effective and safer, Eran Lerer, managing partner, at Shoni Health Ventures, told BioWorld. BioWorld.]]> http://www.bioworld.com/articles/731366 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731366-medical-devices-evolving-into-intelligent-adaptive-systems Feminai patch and app Feminai Ltd. combines a disposable wearable patch with an app to help women screen for breast cancer at home. Credit: Feminai Ltd. Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14. http://www.bioworld.com/articles/731365 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731365-life-sciences-sweet-opportunity-in-us-china-talks China and U.S. flags Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death. http://www.bioworld.com/articles/731329 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731329-elixir-dynamx-system-sees-lower-event-rates-than-drug-eluting-stent Elixir Medical DynamX Dynamx coronary drug-eluting bioadaptor system. Credit: Elixir Medical Corp. Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success. http://www.bioworld.com/articles/731328 Tue, 19 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731328-boston-scientific-reports-seismiq-ivl-data-from-fracture-study Boston Sci Seismiq 4CE coronary IVL catheter Seismiq 4CE coronary IVL catheter. Credit: Boston Scientific Corp.