Medical Device Developments Weekly

Medical Device Developments Weekly

For 44 years, Strain Measurement Devices has built an exceptional level of trust across diverse markets. Whether it is a noninvasive flow sensor for medical device manufacturers, a rugged pressure sensor for oil and gas exploration, or a miniature load cell sensor for aerospace applications, our customers need the utmost confidence in the sensors they embed in the heart of their devices. For unerring accuracy and exceptional long-term performance, they depend on SMD Sensors.

Welcome to this week's Medical Device Developments newsletter.

See the latest insight and analysis from the global medical device market from the last week below:


Reflow Medical recruits first patient in Spur Elute trial for in-stent restenosis

?? Reflow Medical recruits first patient in Spur Elute trial for in-stent restenosis  The study, known as DEEPER CORONARY, will recruit 10 patients at up to three centres in New Zealand.  New Zealand’s Wellington Hospital interventional cardiologist and trial principal investigator Scott Harding said: “It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis.”  Spur Elute addresses coronary ISR in patients by delivering a proprietary sirolimus drug formulation directly to the affected lesion without the use of a permanent metallic implant.  Read more online: https://lnkd.in/ebBpZ3y4  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

The study, known as DEEPER CORONARY, will recruit 10 patients at up to three centres in New Zealand.

New Zealand’s Wellington Hospital interventional cardiologist and trial principal investigator Scott Harding said: “It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis.”

Read more


SpineCraft and Spartan Medical Inc. announce strategic partnership

?? SpineCraft and Spartan Medical Inc. announce strategic partnership  This partnership announcement furthers an existing relationship and collaboration between the two organizations, expanding access to SpineCraft’s portfolio to physicians and patients at VA and DoD medical facilities worldwide.   “As the spinal industry has evolved, we’ve seen an exponential race to the bottom driven by lower cost demands from hospital systems and group purchasing organizations (GPOs),” said Vince Proffitt, Founder & President of Spartan Medical Inc..  Wagdy Asaad, MD, President & CEO of SpineCraft expressed similar enthusiasm for the strategic partnership with Spartan, stating “we are excited to further grow our relationship with Spartan Medical in the federal government.”  Read more online: https://lnkd.in/eQnhd7v3  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

This partnership announcement furthers an existing relationship and collaboration between the two organizations, expanding access to SpineCraft’s portfolio to physicians and patients at VA and DoD medical facilities worldwide.

“As the spinal industry has evolved, we’ve seen an exponential race to the bottom driven by lower cost demands from hospital systems and group purchasing organizations (GPOs),” said Vince Proffitt, Founder & President of Spartan Medical Inc..

Read more


Avicenna.AI secures MDR certification for its AI imaging portfolio

?? Avicenna.AI secures MDR certification for its AI imaging portfolio  The certification was granted by BSI Medical Devices, an EU Notified Body that provides quality management reviews and CE certifications for medical device manufacturers around the world.  With the MDR certification, the company’s product portfolio becomes fully compliant with the EU MDR 2017/745 regulation, which is now mandatory for medical device companies in Europe.  The MDR-certified AI tools include algorithms for intracranial haemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), and quantification of stroke severity (CINA-ASPECTS).  Read more online: https://lnkd.in/eiF2R4e6  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

The certification was granted by BSI Medical Devices, an EU Notified Body that provides quality management reviews and CE certifications for medical device manufacturers around the world.

With the MDR certification, the company’s product portfolio becomes fully compliant with the EU MDR 2017/745 regulation, which is now mandatory for medical device companies in Europe.

Read more


Why Medical Device Developments is the first choice for medical device manufacturing professionals The authoritative voice of the medical device industry, Medical Device Developments is leading the debate on the evolution of the market through extensive research, data analysis, policy reports and up-to-the-minute reporting from the medical device industry.  Medical Device Developments is the premier information source for the world’s major medical device manufacturers/OEMs to help them make critical business decisions.  Aimed at senior executives, Medical Device Developments provides a clear overview of the latest thinking regarding the role of technology.  Medical Device Developments is supported across a number of platforms online and is positioned as the definitive destination for medical device manufacturing professionals. We are driven by unbiased and authoritative editorial content brought to you by an expert team of journalists with unrivalled industry expertise.

KORU Medical Systems’s FreedomEdge syringe infusion system approved in Japan

?? KORU Medical Systems’s FreedomEdge syringe infusion system approved in Japan  The infusion system is indicated for the delivery of multiple drugs, including CSL Behring’s Hizentra, Takeda’s Cuvitru SCIg, and Sobi’s Aspaveli.  According to KORU Medical Systems, the regulatory approval marks a significant advancement in patient care in Japan.  It provides patients and healthcare providers with access to new treatment options for subcutaneous immunoglobulin (SCIg) therapy and paroxysmal nocturnal haemoglobinuria (PNH).  Read more online: https://lnkd.in/edUFD9aP  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

The infusion system is indicated for the delivery of multiple drugs, including CSL Behring’s Hizentra, Takeda’s Cuvitru SCIg, and Sobi’s Aspaveli.

According to KORU Medical Systems, the regulatory approval marks a significant advancement in patient care in Japan.

Read more


SOPHiA GENETICS integrates Dhiti Omics on SOPHiA DDM Platform

?? SOPHiA GENETICS integrates Dhiti Omics on SOPHiA DDM Platform  The SOPHiA DDM Platform analyses complex genomic and multimodal data to deliver real-time, actionable insights to a diverse global network including hospitals, laboratories, and biopharma institutions.  Dhiti Omics will use the SOPHiA DDM Platform technology to improve its solid tumour testing capabilities.  The company specialises in molecular diagnostics and genetic testing.  Read more online: https://lnkd.in/eBpQA6KP  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

The SOPHiA DDM Platform analyses complex genomic and multimodal data to deliver real-time, actionable insights to a diverse global network including hospitals, laboratories, and biopharma institutions.

Dhiti Omics will use the SOPHiA DDM Platform technology to improve its solid tumour testing capabilities.

Read more


Carmat secures equity financing from Vester Finance SA for artificial heart

?? Carmat secures equity financing from Vester Finance SA for artificial heart  The French medical technology firm designs, manufactures, and markets the Aeson artificial heart.  The agreement with Vester Finance SA allows for the issuance of a maximum of 3.5 million shares over 24 months.  Under the deal, Vester Finance will subscribe to CARMAT’s ordinary shares at a maximum of 9.96% of the latter’s current share capital, at its discretion and subject to standard contractual conditions.  Read more online: https://lnkd.in/eHppBfmv  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  hashtag#MedicalDeviceDevelopments hashtag#medicaldevices hashtag#medicalmanufacturing

The French medical technology firm designs, manufactures, and markets the Aeson artificial heart.

The agreement with Vester Finance SA allows for the issuance of a maximum of 3.5 million shares over 24 months. Under the deal, Vester Finance will subscribe to CARMAT’s ordinary shares at a maximum of 9.96% of the latter’s current share capital

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Recommended webinars H&T Presspart: Transitioning pMDI’s products with Low Global Warming Propellants Meridian Bioscience: The Evolution of STI At-Home Testing Solutions DuPont Liveo: Introducing new DuPont? Liveo? MG 7-9960 Soft Skin Adhesive WuxiApptec: Designing Extractable/Leachable Studies for Drugs and Biologics Loftware Siemens: The challenge of labeling & UDI for medical device Particle Measuring Systems: Environmental Monitoring Compliance Learning from FDA Warning Letters Rockwell Automation: A Unified Data Platform Delivers Integrated PAT and CPV

Recommended webinars


Thanks for reading; we hope you enjoyed it.

Until next week.

To have a story featured on next week's newsletter - contact Medical Device Developments or Jamie Mann directly.

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