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MARCH 2, 2023

Apyx Medical Corporation (NASDAQ:APYX) , the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion ® , today announced it has received 510(k) clearance from the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space. Are you hiring?

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DECEMBER 1, 2022

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. market today. Press Release by: HemoSonics, LLC. Are you hiring?

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NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.

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MAY 30, 2023

Food and Drug Administration (FDA). It’s been exciting supporting this project from early concept development through transfer-to-manufacture, and we look forward to its commercial success,” said Duncan Smith, managing partner of Sagentia Innovation. THINK Surgical, Inc., About THINK Surgical, Inc.

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JULY 14, 2023

Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation. In addition, AceConnex Pre-Sutured Fascia is manufactured to ensure consistency and minimize variability compared to allografts that are manually sutured pre-operatively. Are you hiring?

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Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. 3D printing.

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DECEMBER 16, 2022

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System.

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European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What are the top three supply-related challenges facing pharmaceutical manufacturers?

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Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. mm to 6 mm in diameter. Surmodics is headquartered in Eden Prairie, Minnesota.

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APRIL 12, 2023

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

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OCTOBER 9, 2023

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.

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PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. From the manufacturer perspective, payer policies and legislation on combination therapy pricing are impacting global development, pricing, access, and commercialization strategies.

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OCTOBER 25, 2022

Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

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APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. restor3d, a research-driven medical device company, announced that the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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MAY 18, 2023

Food and Drug Administration has granted the Connexus DDI “Breakthrough Device Designation”, which offers an expedited review process for transformative medical devices with the potential to treat irreversibly debilitating conditions. .” In addition to the funding, Paradromics announced that the U.S.

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SEPTEMBER 20, 2022

Food & Drug Administration (“FDA”) for the SavvyWire (“SavvyWire”), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment.

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European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

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PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public.

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JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM Infusion System as compared to vials.

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Medico Reach

JULY 3, 2022

Begin Preparation Before FDA Approval. Before marketing the device, a pre-market submission and approval are required by Food and Drug Administration FDA. The launch date may be closer than you believe with the FDA’s unpredictable timeframe. Create a Marketing Plan.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. However, another study found that 0.1% 2] Figure 1.

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AUGUST 10, 2023

Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. “A massive inflection point in our device development journey” Acorai’s CEO and Co-Founder Filip Peters said, “We could not be more delighted with the decision from the FDA, and it constitutes a huge milestone for us as a company.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. Blockchain technology creates a decentralised and unalterable ledger that records all transactions across a network of computers.

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JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. We intend to work closely with the FDA to determine a timely pathway to bring the SING IMT to market in the United States.”. There is no cure for late-stage AMD.

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DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. and Israel. Are you hiring?

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MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe. Are you hiring?

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OCTOBER 27, 2023

Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. FDA in April 2023 for use with an implant from a single implant manufacturer. THINK Surgical, Inc., THINK Surgical is committed to an open implant library. THINK Surgical, Inc., Are you hiring?

Specialization 52

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European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

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Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. ” This latest FDA clearance for the EyeArt v2.2.0

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JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Tyber Medical is committed to providing rapid access to FDA-cleared and CE-marked private label, orthopedic device technology that advance patient care and healing outcomes. About Tyber Medical LLC.

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SEPTEMBER 21, 2023

Food and Drug Administration (FDA) to market the Blackhawk ® Ti 3D Printed Cervical Spacer System with standalone clearance. Altus Capital Partners is a private equity firm that controls investments in middle-market manufacturing businesses. For more information, please visit www.choicespine.com.

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European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. 2 Yet according to a 2022 report by GlobalData, it is difficult to achieve high quality and highly pure mRNA via scalable manufacturing.

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Pharmaceutical Technology

JUNE 30, 2022

This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”. Bolkvadze predicts that another challenge may be found in the increased volume of operations, leading to a capacity shortage.

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