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Home » Authors » Annette Boyle

Annette Boyle

Articles

ARTICLES

Prostate cancer tissue section overlaid with data from the Visium Spatial Gene Expression for FFPE

10x Genomics’ Visium assay brings whole transcriptome into view

June 11, 2021
By Annette Boyle
10x Genomics Inc. began distribution of its new Visium Spatial Gene Expression for FFPE (formalin-fixed and paraffin-embedded) assay in the U.S., giving researchers access to whole transcriptome spatial gene expression across entire FFPE tissue samples. The assay allows researchers to overcome the challenges in transcriptome analysis created by FFPE processing.
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Neurescue device image

Neurescue’s aortic occlusion device gets FDA nod for hemorrhage and IDE for cardiac arrest

June 10, 2021
By Annette Boyle
The FDA granted Neurescue a "two-fer" on its intelligent balloon catheter for aortic occlusion with 510(k) clearance for emergency control of hemorrhage and investigational device exemption for use in cardiac arrest. By inflating a soft balloon at diaphragm level, the device dramatically increases perfusion to the heart, brain and lungs within a minute of deployment via the femoral artery.
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Vanta device image

FDA backs Medtronic implantable neurostimulator with 11-year life

June 10, 2021
By Annette Boyle
Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals.
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Knee pain illustration

FDA clearance gives Cymedica a leg up on osteoarthritis knee pain

June 9, 2021
By Annette Boyle
Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy.
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Stop sign

FDA issues clinical hold on Ortho's IND application for Ortho-R clinical trial

June 4, 2021
By Annette Boyle
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
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Illustration of brain computer interface in brain

Synchron gathers series B $40M for minimally invasive implantable brain-computer interface

June 3, 2021
By Annette Boyle
Synchron Inc. landed $40 million in new funding through a series B fundraising round led by Khosla Ventures. This round brings the total amount raised by the company to $59 million since its founding in 2016. Other participants in the round included Forepont Capital Partners, ID8 Investments, Shanda Group, General Advance, Subversive Capital, and Re.mind Capital as well as Arani Bose and Thomas Reardon. Returning investors included Neurotechnology Investors, Metis Innovative, and the University of Melbourne.
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Avagen product packaging

Avellino offers insight into common cause of blindness with genetic test

June 2, 2021
By Annette Boyle
With the rollout of its Avagen test, Avellino Lab USA Inc. hopes to see a significant change in the diagnosis and management of keratoconus, a common cause of blindness. The test quantifies the risk of keratoconus and definitively diagnoses other corneal dystrophies, which are frequently misdiagnosed or undiagnosed until late in their development, when treatment is less effective and vision already impaired.
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Scopio's digital blood smear analysis tool

Scopio re-envisions blood analysis

May 28, 2021
By Annette Boyle
Hematologists juggle two competing needs, and often multiple lenses, to really see what’s happening in a blood sample. Essentially, they need to see both the veins on an individual leaf and the forest, but lack a digitized system that can provide images of both. Scopio Labs Ltd.’s recently FDA-approved X100 with Full Field Morphology Peripheral Blood Smear (FFM-PBS) application addresses this need by combining computational photography imaging with artificial intelligence tools.
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Tired mother holding newborn

Woebot cheered by FDA breakthrough device designation for postpartum depression treatment

May 26, 2021
By Annette Boyle
Woebot Labs Inc. got a bit of a pick-me-up with the FDA's decision to grant breakthrough device designation to the company's digital therapeutic for postpartum depression. The WB001 app combines cognitive behavioral therapy with interpersonal psychotherapy and an understanding of how postpartum depression affects interactions and daily life. The investigational treatment is designed as an eight-week, prescription-only intervention for women under a physician’s care.
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Close-up of eye

All eyes are on autism screening app for toddlers

May 25, 2021
By Annette Boyle
With the support of the NIH’s National Institute of Child Health and Human Development and the National Institute of Mental Health, researchers at Duke University’s Center for Autism and Brain Development have developed a mobile app that can quickly screen toddlers for autism spectrum disorder without the need for specialized skills.
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View All Articles by Annette Boyle

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