MedTech

StageBio Acquires TPL Path Labs to Expand its Footprints Globally

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Shots: StageBio and TPL Path Labs offers an expanded array of histopathology, molecular pathology, and related solutions to biopharma, medical device and academic researchers across the US, EU, and other countries The acquisition expands StageBio’s pre/ clinical laboratory resources, GLP/GCLP-compliant lab facility and staff in… Read More »StageBio Acquires TPL Path Labs to Expand its Footprints Globally

Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

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Shots: The agreement leverages Imbio’s technical, regulatory & commercial expertise to build medical imaging AI technology for use in research, clinical trials & clinical practice The focus of the agreement is to develop quantitative imaging diagnostics for lung diseases and to bring unique solutions for… Read More »Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging

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Shots:   The company reports NDA submission and request for PR to the US FDA for hyperpolarised 129Xenon gas used to evaluate the pulmonary function and to visualize the lung using MRI. The NDA submission follows the completion of two P-III studies, demonstrating the effective measurement… Read More »Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging

Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

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Shots: Onvision needle tip tracking technology will be exclusively available on the latest version of the B. Braun and Philips’ Xperius ultrasound system together with the Stimuplex Onvision needle, empowering anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia. It… Read More »Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

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Shots: Lineagen to receive $9.6M consisting of 6,167,510 shares of Bionano’s common stock, ~ $1.7M in cash and assumption of ~$2.9M in liabilities. The acquisition complements Binano by adding leading cytogeneticists, genetic counselors, laboratory operations and billing experts, clinical commercialization experts, and payor contracts The… Read More »Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

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Shots: Qiagen’s QIAseq SARS-CoV-2 primer panel provides optimized, single-day workflows to prepare libraries for sequencing as researchers use NGS to track changes in the viral genome The two-step process uses advanced QIAseq technologies to conduct reverse transcription and cDNA synthesis from a viral RNA sample,… Read More »Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

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Shots: The acquisition will expand Medtronic’s capabilities to serve people using multiple daily injections (MDI) to manage diabetes with the addition of Companion Medical’s InPen to Medtronic’s portfolio. The acquisition is expected to be closed within 1-2mos. Medtronic will advance the automation of insights and… Read More »Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

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Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about… Read More »The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

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Shots: The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments… Read More »Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

AstraZeneca Collaborates with Eko to Advance the Digital Health Tools for the Diagnosis of CV Diseases

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Shots: The two companies collaborated to facilitate the development of digital health tools for the earlier screening of cardiovascular diseases, including HF AstraZeneca and Eko will accelerate the development of Eko algorithms, enhancing clinical trials with Eko technology, and potentially building new HF detection solutions.… Read More »AstraZeneca Collaborates with Eko to Advance the Digital Health Tools for the Diagnosis of CV Diseases

Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

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Shots: The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC medications. The study met its 1EPs demonstrating a low rate of major procedure-related safety events (0.5% @7days post-procedure) and high… Read More »Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

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Shots The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future In Nov’2019, FullFocus… Read More »Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

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Shots: The real-world evidence partnership will allow the Roche to access PicnicHealth’s set of de-identified patient records to gain insights on certain diseases and treatments The collaboration will initially focus on MS and may be extended to support Huntington’s disease (HD), paroxysmal nocturnal hemoglobinuria (PNH),… Read More »Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis