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Diagnostic Spirometer Medical Device Articles & Analysis

66 news found

Biopharma PEG Achieves FDA DMF Approval for HZ-PEG-HZ

Biopharma PEG Achieves FDA DMF Approval for HZ-PEG-HZ

Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. The assigned DMF number is 041864. This significant achievement underscores Biopharma PEG's robust ...

ByBiopharma PEG Scientific Inc


CELLVIE wins the prestigious MedTech Innovator Value Award

CELLVIE wins the prestigious MedTech Innovator Value Award

MedTech Innovator is the leading program for medical devices, digital health and diagnostic companies and is the largest accelerator for life science companies globally. Every year, start-ups from all over the world are invited to present their solution and vision for a chance to be selected to join the MedTech Innovator Accelerator. The program culminates in a competition for a grand prize of ...

Bycellvie Inc.


Kephera Diagnostics receives $417,074 grant award from the Massachusetts Life Sciences Center to accelerate development of its rapid COVID-19 Antigen Test

Kephera Diagnostics receives $417,074 grant award from the Massachusetts Life Sciences Center to accelerate development of its rapid COVID-19 Antigen Test

Today, the Baker-Polito Administration announced that more than $1.5 million has been awarded to four projects that seek to increase testing capacity and provide solutions for coronavirus testing. The funding is through the Accelerating Coronavirus Testing Solutions (A.C.T.S.) Program, designed and administered by the Massachusetts Life Sciences Center, which supports projects focused on two core ...

ByKephera Diagnostics, LLC


Vice President of Product Marketing Tommy Carls Featured in Medical Device and Diagnostic Industry

Vice President of Product Marketing Tommy Carls Featured in Medical Device and Diagnostic Industry

Proprio’s vice president of product management and marketing, Tommy Carls, has been featured in Medical Device and Diagnostic Industry (“MD&DI”). Carls’ thought leadership piece, “Bringing Intentionality & Defined Purpose to the Road to Data Intelligence” highlights the undervalued influence of healthcare data, and the potential impacts of more ...

ByProprio, Inc.


The Lancet Oncology: 66% of diagnostic biopsies for common skin cancer can be avoided using Michelson Diagnostics’ VivoSight OCT laser scanner

The Lancet Oncology: 66% of diagnostic biopsies for common skin cancer can be avoided using Michelson Diagnostics’ VivoSight OCT laser scanner

A major study published in leading cancer journal, The Lancet Oncology1 have ground-breaking findings on Michelson Diagnostics, the UK based medical device company that use multi-beam Optical Coherence Tomography (‘OCT’) technology, which can transform patient’s treatment and care of basal cell carcinomas (BCC). It was concluded that OCT-guided diagnosis, when compared to a ...

ByMichelson Diagnostics Ltd. (MDL)


STEMart Introduces New Antibiotic Potency Tests for Medical Devices

STEMart Introduces New Antibiotic Potency Tests for Medical Devices

STEMart, a provider of CRO services dedicated to integrated medical device and diagnostic clinical development, introduced new Antibiotic Potency Tests to assess the bioactivity or potency of various antibiotics for medical devices. The development of these new tests strictly follows the Antibiotics-Microbial Assays in USP General Chapter 81 to ensure the highest efficacy. Microbial potency ...

BySTEMart


Lazurite™ Named One of the Industry’s Hottest Companies by World’s Largest MedTech Accelerator

Lazurite™ Named One of the Industry’s Hottest Companies by World’s Largest MedTech Accelerator

MedTech Innovator, the world’s largest accelerator of medical technology companies, yesterday named Lazurite as one of the MedTech industry’s hottest 50 companies by selecting it to participate in Medtech Innovator’s flagship four-month Accelerator program featuring medical device, diagnostic, and digital health technologies from around the globe. As a 2022 Cohort member, ...

ByLazurite Holdings LLC.


Anavasi Diagnostics Announces Appointment of Scott Robitaille As Vice President Of Sales And Marketing

Anavasi Diagnostics Announces Appointment of Scott Robitaille As Vice President Of Sales And Marketing

Anavasi Diagnostics ('Anavasi'), a medical technology company focused on the development of novel molecular diagnostic testing, has announced the addition of Scott Robitaille as Vice President of Sales & Marketing. Robitaille joins Anavasi with in-depth knowledge of the medical device and molecular diagnostics sector and over two decades of sales, marketing, and channel management ...

ByAnavasi Diagnostics


STEMart Introduces Biocompatibility Evaluation of Breathing Gas Pathways in Medical Devices

STEMart Introduces Biocompatibility Evaluation of Breathing Gas Pathways in Medical Devices

STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, expands its Biocompatibility Testing services and introduces biocompatibility evaluation of breathing gas pathways in medical devices. This new testing follows the biocompatibility guidelines modified for medical devices and uses a solid scientific rationale. ...

BySTEMart


PAVmed PAVmed Provides Business Update and Preliminary First Quarter 2022 Financial Results

PAVmed PAVmed Provides Business Update and Preliminary First Quarter 2022 Financial Results

PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”) and Veris Health Inc. (“Veris”), and ...

ByPAVmed Inc.


STEMart Launches Pyrogenicity Testing Service for Medical Devices

STEMart Launches Pyrogenicity Testing Service for Medical Devices

STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...

BySTEMart


Signifier Medical Technologies Announces $49MM Purchase of Existing Shares by Waha Capital, Angelus Sano Ventures and Segulah Medical Acceleration

Signifier Medical Technologies Announces $49MM Purchase of Existing Shares by Waha Capital, Angelus Sano Ventures and Segulah Medical Acceleration

Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced that Waha Capital PJSC (“Waha Capital”), Angelus Sano Fund L.P. (“Angelus”), Segulah Medical Acceleration AB (“Segulah Medical”) and certain other individual investors have collectively invested approximately $49 ...

BySignifier Medical Technologies Ltd


Medovate Joins Abhi Us Accelerator 2022 Cohort

Medovate Joins Abhi Us Accelerator 2022 Cohort

Medovate is delighted to be joining the Association of British HealthTech Industries (ABHI) US Accelerator 2022 cohort. The dynamic Cambridge-based development company, who are helping to bring to life pioneering medical devices, is participating in the programme for a second year running. Now in its fifth year, the ABHI US Accelerator, conducted in partnership with the Dell Medical School in ...

ByMedovate


Eg Technology And Health Enterprise East Announce Winners Of The 2021 Innovation Voucher Award

Eg Technology And Health Enterprise East Announce Winners Of The 2021 Innovation Voucher Award

Following the success of the 2020 Innovation Voucher Award, won by Mr Ryan Mathew and Dr Heiko Wurdak for their Mini-brain benchtop test, eg technology and Health Enterprise East (HEE) are pleased to announce, not one, but two joint winners of this year’s Innovation Voucher Award. Having received numerous applications covering a fascinating range of emerging medical technologies, this ...

Byeg Technology Ltd


Dexter Series E: $90M to Make Sense of Robotic Surgery

Dexter Series E: $90M to Make Sense of Robotic Surgery

Distalmotion, Revival Healthcare Capital and 415 CAPITAL announce the closing of a USD 90 million Series E financing round to accelerate the adoption of Distalmotion’s surgical robot Dexter. The investment follows Dexter’s successful initial clinical use and supports Distalmotion’s international commercial scaling. More than capital: A partnership of medtech pioneers and ...

ByDistalmotion SA


EIB backs Belgian rapid COVID-19 PCR Test developer miDiagnostics

EIB backs Belgian rapid COVID-19 PCR Test developer miDiagnostics

miDiagnostics has been granted a €20 million loan from European Investment Bank to scale up its research and development activities and accelerate the market launch of its diagnostics solution. With EU backing, the EIB financing will strengthen home-grown European technology that can play an important role in helping to bring the pandemic under control. The transaction is supported by ...

BymiDIAGNOSTICS


Inflammatix Appoints Dr. Kian Beyzavi as New Board Member

Inflammatix Appoints Dr. Kian Beyzavi as New Board Member

Inflammatix, a pioneering molecular diagnostics company, announced today the appointment of Kian Beyzavi, PhD, as an independent member of the company’s board of directors. Dr. Beyzavi is a seasoned veteran of the healthcare industry with significant operating experience in the medical device and diagnostics industries, and a focus on leveraging innovative technologies to improve diagnosis ...

ByInflammatix, Inc.


New Rapid Molecular COVID-19 Test from Anavasi Diagnostics Awarded $14.9 Million by NIH to Accelerate Test Availability

New Rapid Molecular COVID-19 Test from Anavasi Diagnostics Awarded $14.9 Million by NIH to Accelerate Test Availability

Anavasi Diagnostics, a medical technology company focused on the development of novel molecular diagnostic testing using a proprietary patent-pending reverse transcriptase methodology, today announced it has been awarded $14.9 million from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative. The funding will accelerate the launch and broad market ...

ByAnavasi Diagnostics


CorWave Wins 2021 Healthtech Award

CorWave Wins 2021 Healthtech Award

CorWave, a French medtech company developing a nextgeneration heart pump, won the 2021 Healthtech Award in the Medtech category yesterday. Organized by France Biotech, the French professional association of healthtech entrepreneurs, the event rewards the companies that have made the biggest impact on the sector this year. 109 companies submitted applications for the 2021 Healthtech Awards. ...

ByCorWave


Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics, an innovative leader in providing cutting-edge breath tests intended for routine use in diagnostic medicine, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of the Company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include “at home” administration under virtual supervision of Cairn Diagnostics. GEBT ...

ByCairn Diagnostics

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