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Deals and Financings

Set Alert for Deals

News We’re Watching: Edwards Scoops Up Cardio Firms, BD And Quest Partner, Admera Settles Kickback Case

This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the government $5m for violating anti-kickback law; eCential Robotics’ spine platform made its debut for human use; and more.

Commercial Regulation

Biolinq Aims To Transform Diabetic Glucose Monitoring With Needle-Free Patch

Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

Diabetic Care Innovation

TRiCares Secures $50M For Tricuspid Replacement System, Topaz

TRiCares SAS announced it raised $50m in series D funding from a single unnamed investor. The funding will support the company’s upcoming US early feasibility study and EU CE mark clinical investigation for its transfemoral tricuspid heart valve replacement system, Topaz.

Europe US States

Magenta Medical Secures $105M To Advance ‘World's Smallest Heart Pump’

Magenta Medical is preparing to launch a pivotal trial for its Elevate percutaneous Left Ventricular Assist Device, armed with $105m in new funding announced on 23 July. The company’s minimally invasive, FDA-designated Breakthrough Device supports heart function during high-risk percutaneous coronary intervention procedures.

Europe US States

News We’re Watching: Nipro Medical Invests $397.8M In First US Facility; Baxter, Hamilton Ventilator Recalls; FDA Warnings; And More

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

News We're Watching Approvals

Truvian Health Raises $74M In Funding For Automated Benchtop Blood Testing Analyzer, Pursues FDA Clearance

Truvian Health said it raised $74m in venture capital funding, which the company plans to use in part to try to secure US FDA clearance for its blood testing platform.

Financing Commercial

Cumulus Neuroscience Joins Transatlantic Hunt For Alzheimer’s Blood And Digital Biomarkers

Cumulus Neuroscience has been granted £1.2m from Innovate UK to validate AccelADx, an AI-powered, non-invasive Alzheimer’s screening test that combines EEG and tablet-based assessments, as part of a transatlantic study investigating digital and blood-based biomarkers for Alzheimer's dementia.

Research & Development Financing

Endoron Staples Down $10M To ‘Revolutionize’ Abdominal Aortic Aneurysm Repair

Endoron Medical won $10m in series A funding from European venture capital firm Sofinnova Partners and the European Innovation Council Fund. The capital will propel Aortoseal – Endoron's endograft stapling solution for abdominal aortic aneurysm – through clinical validation in its US Food and Drug Administration early feasibility study.

Europe US States

Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study

In a pilot study building on previously published Phase 2 trial results, Sinaptica’s precision therapy, combining repetitive transcranial magnetic stimulation with EEG monitoring and artificial intelligence, showed macro- and micro-structural grey matter preservation and increased functional connectivity in Alzheimer’s patients versus a sham treatment arm.

Research & Development Financing

Syphilis OTC Test Developer NOWDiagnostics Raises $22.5M

The Series B funding round led by DigitalDx Ventures will support development and commercialization of more than 30 rapid diagnostic tests in NOWDx’s clinical research pipeline, including its First To Know Syphilis OTC test, currently under US FDA De Novo review, which provides at-home results in minutes.

Financing Diagnostics

News We’re Watching: FDA Issues Monkeypox EUAs, IMDRF Publishes AI Principes, Quest Buys LifeLabs

This week, the US FDA authorized EUAs for at-home mpox tests and announced a public workshop on implanted brain devices; the IMDRF published guiding principles on good machine learning practices for AI; and Quest announced its deal to acquire a Canadian diagnostic firm.

Regulation Commercial

Deals Shaping The Medtech And Diagnostics Industries, June 2024

An interactive look at medtech and diagnostics deals made during June 2024. Data courtesy of Biomedtracker.

Deals Financing

News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

Regulation Commercial

Deloitte Tackles Pros and Cons of Europe For Medtech

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

Europe Market Intelligence

Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

Women's Health Financing

News We’re Watching: Medtronic Recall, More Chinese Syringe Woes, Surgical Robot Clearance

This week, Medline announced recalls of tracheal tubes; Eko Health raised $41m in Series D funding; and the US FDA announced participation in collaborative communities focused on brain-computer interface devices and more.

Approvals FDA
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